YKL-40 in Serum Samples From Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy

Study Description

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Brief Summary:

This research trial studies chitinase 3-like 1 (cartilage glycoprotein-39) (YKL-40) in serum samples from patients with newly diagnosed stage III-IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer receiving chemotherapy. Studying samples of serum in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. It may also help doctors understand how well patients respond to treatment.

Condition or disease

Intervention/treatment

Fallopian Tube Adenocarcinoma; Fallopian Tube Clear Cell Adenocarcinoma; Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube Mucinous Adenocarcinoma; Fallopian Tube Serous Adenocarcinoma; Fallopian Tube Transitional Cell Carcinoma; Malignant Ovarian Brenner Tumor; Malignant Ovarian Clear Cell Tumor; Malignant Ovarian Endometrioid Tumor; Malignant Ovarian Mixed Epithelial Tumor; Malignant Ovarian Mucinous Tumor; Malignant Ovarian Neoplasm; Malignant Ovarian Serous Tumor; Malignant Ovarian Transitional Cell Tumor; Ovarian Adenocarcinoma; Primary Peritoneal Serous Adenocarcinoma; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer; Undifferentiated Fallopian Tube Carcinoma; Undifferentiated Ovarian Carcinoma

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the ability of the YKL-40 serum marker to detect response or lack of response to primary chemotherapy in International Federation of Gynecology and Obstetrics (FIGO) stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.

II. To compare the predictive accuracy of YKL-40 with cancer antigen 125 (CA125).

SECONDARY OBJECTIVES:

I. To test the ability of the YKL-40 serum marker to detect recurrence of ovarian, primary peritoneal, or fallopian tube cancer in patients who are in first remission following primary chemotherapy.

II. To test the ability of the YKL-40 serum marker to predict poor risk patients with FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer.

TERTIARY OBJECTIVES:

I. To explore alternative cut-off values for YKL-40 elevation in this large patient population.

II. To describe the variability of YKL-40 and CA125 measurements in patients receiving primary chemotherapy and in primary remission in a large patient population.

III. To describe the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response, progression-free survival and overall survival.

OUTLINE:

Patients undergo collection of serum samples for analysis of YKL-40 via enzyme-linked immunosorbent assay (ELISA) and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.

Study Design

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Study Type :	Observational
Estimated Enrollment :	2500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A Prospective, Longitudinal Study of YKL-40 in Patients With FIGO Stage III or IV Invasive Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer Undergoing Primary Chemotherapy
Study Start Date :	September 2007
Estimated Primary Completion Date :	January 2100

Groups and Cohorts

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Group/Cohort

Intervention/treatment

Ancillary-Correlative (serum collection for YKL-40 and CA125); Patients undergo collection of serum samples for analysis of YKL-40 via ELISA and CA125 via chemiluminometric sandwich immunoassay at the following time-points: at baseline; prior to beginning each course of chemotherapy (courses 1-6); at completion of chemotherapy; every 3 months during years 1-2 post-chemotherapy; every 6 months during years 3-5 post-chemotherapy; every year during years 6-10 post-chemotherapy; and at time of disease recurrence or progression.

Other: Cytology Specimen Collection Procedure; Correlative studies; Other Name: Cytologic Sampling Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

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Primary Outcome Measures :

1. CA125 measurements [ Time Frame: Up to 10 years ]
   The accuracy of each marker alone will be compared using area under the ROC curve, and assess which adds more predictive information when both are included in logistic regression.
2. Objective response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: Up to 10 years ]
   In order to make a valid comparison between CA125 and YKL-40, in this study computed tomography (CT) criteria will be treated as the "gold standard" and whether changes in YKL-40 levels correlate with CT evidence as well as or better than changes in CA125 levels will be evaluated.
3. Time to disease progression using RECIST criteria [ Time Frame: Up to 10 years ]
   Parallel statistical analyses of time to disease progression will also be conducted for patients who do not respond.
4. Time to tumor recurrence (relapse) [ Time Frame: From study entry until disease recurrence, death or date of last contact, assessed up to 10 years ]
   Parallel analyses of the markers as predictors of time-to-relapse will be performed using survival-type regression methods such as the Cox proportional hazards model or a parametric maximum likelihood model. The total number of patients available for analysis of time to relapse is the number of patients who respond to treatment.
5. YKL-40 measurements [ Time Frame: Up to 10 years ]
   YKL-40 will be compared to CA125 in terms of its ability to detect response to chemotherapy (during chemotherapy) and recurrence of disease (in remission). Serum YKL-40 behavior will also be assessed as a reflection of tumor histology, tumor grade, and tumor stage—all in comparison to CA125. The accuracy of each marker alone will be compared using area under the receiver operating characteristic (ROC) curve, and assess which adds more predictive information when both are included in logistic regression.

Other Outcome Measures:

1. Chemotherapy response [ Time Frame: Up to 10 years ]
   As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting chemotherapy response will be described.
2. Optimal cut-off values for YKL-40 [ Time Frame: Up to 10 years ]
   Optimal cut-off values for YKL-40 that subsequently can be used in clinical practice will be determined. Any statistical significance calculated for an optimized cut-off will adjust for the selection process, and any comparison with CA-125 will treat both markers in the same way.
3. Overall survival [ Time Frame: From entry into the study to death or the date of last contact, assessed up to 10 years ]
   As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting overall survival will be described.
4. Progression-free survival [ Time Frame: From study entry until disease progression, death or date of last contact, assessed up to 10 years ]
   As an exploratory analysis, the accuracy of YKL-40 coupled with CA125 measurements in predicting progression-free survival will be described.
5. Variability of CA125 measurements [ Time Frame: Up to 10 years ]
   Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of CA125 over time in this population.
6. Variability of YKL-40 measurements [ Time Frame: Up to 10 years ]
   Linear statistical methods, such as a random effects model, will be used to assess the variability and correlation of YKL-40 over time in this population.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients With Newly Diagnosed Stage III-IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer Receiving Chemotherapy

Criteria

Inclusion Criteria:

• Patients with a histologic diagnosis of FIGO stage III or IV invasive epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who will receive primary chemotherapy for newly diagnosed disease; eligible histologic cell types include serous, mucinous, endometrioid, clear cell, transitional, mixed epithelial, undifferentiated, adenocarcinoma, not otherwise specified (NOS) and malignant Brenner tumor
• Patients who have undergone full surgical staging as described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
• Patients who have met the pre-entry requirements
• Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

• The following histologic cell types are not eligible: carcinosarcoma (malignant mixed Mullerian tumor) and borderline epithelial tumors (low malignant potential, atypical proliferative)
• Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage IA or IB low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
• Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than IB; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
• With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded
• Patients who receive neoadjuvant chemotherapy prior to surgical staging
• Individuals with a diagnosis of rheumatoid arthritis, severe uncontrolled osteoarthritis, hepatic fibrosis or other active chronic inflammatory condition

Contacts and Locations

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Locations

United States, Alabama
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
United States, Arizona
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Arkansas
Highlands Oncology Group PA - Fayetteville
Fayetteville, Arkansas, United States, 72703
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
Central Georgia Gynecologic Oncology
Macon, Georgia, United States, 31201
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Saint Anthony's Health
Alton, Illinois, United States, 62002
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Carle Cancer Center
Urbana, Illinois, United States, 61801
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Kansas
Providence Medical Center
Kansas City, Kansas, United States, 66112
United States, Kentucky
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States, 41017
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
United States, Maine
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
Beaumont Hospital-Dearborn
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, United States, 49442
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Lake Huron Medical Center
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States, 65804
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Island Gynecologic Oncology
Brightwaters, New York, United States, 11718
New York Hospital Medical Center of Queens
Fresh Meadows, New York, United States, 11365
Winthrop University Hospital
Mineola, New York, United States, 11501
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, United States, 28401
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States, 27104
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Aultman Health Foundation
Canton, Ohio, United States, 44710
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Main Line Health NCORP
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Black Hills Obstetrics and Gynecology
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Knoxville Gynecologic Cancer Specialists PC
Knoxville, Tennessee, United States, 37920
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States, 76104
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Wisconsin
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Katherine Bell-McGuinn	NRG Oncology

More Information

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Responsible Party:	Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00899093 History of Changes
Other Study ID Numbers:	GOG-0235; NCI-2009-01083 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); CDR0000540250; GOG-0235 ( Other Identifier: NRG Oncology ); GOG-0235 ( Other Identifier: CTEP ); U10CA180868 ( U.S. NIH Grant/Contract ); U10CA027469 ( U.S. NIH Grant/Contract )
First Posted:	May 12, 2009
Last Update Posted:	May 4, 2017
Last Verified:	May 2017

Additional relevant MeSH terms:

Carcinoma; Neoplasms; Adenocarcinoma; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Transitional Cell; Carcinoma, Endometrioid; Cystadenocarcinoma, Serous; Adenocarcinoma, Mucinous; Cystadenocarcinoma; Adenocarcinoma, Clear Cell; Brenner Tumor; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type	Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endometrial Neoplasms