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Lysophosphatidic Acid Assay in Patients With Ovarian Cancer or Who Are at Risk for Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00986206
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Screening tests, such as the lysophosphatidic acid assay, may help doctors find cancer cells early and plan better treatment for ovarian cancer.

PURPOSE: This clinical trial is studying using the lysophosphatidic acid assay to see how well it works in early detection of ovarian cancer in patients with ovarian cancer or who are at risk for ovarian cancer.


Condition or disease Intervention/treatment
brca1 Mutation Carrier brca2 Mutation Carrier Ovarian Cancer Diagnostic Test: Biomarker LPA and HE4

Detailed Description:

OBJECTIVES:

Primary

  • To validate a new assay for lysophosphatidic acid (LPA) in early detection of ovarian cancer.

Secondary

  • To estimate the risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women presenting with a pelvic mass and compare LPA results from both surgical patient groups with those from "normal", disease-free women at high-risk of ovarian cancer.

Tertiary

  • To examine the response to primary adjuvant treatment and recurrence of disease.
  • To evaluate urine levels of CA125 and LPA to determine their ability to estimate the risk of cancer at the time of surgery in patients presenting with a pelvic mass. (exploratory)

OUTLINE: Blood and urine samples are collected before or on the day of surgery; before, during, and after completing chemotherapy; or at a clinic visit. Samples are tested for concentrations of CA125 and lysophosphatidic acid (LPA) using a new assay and compared to liquid chromatography/electrospray ionization-tandem mass spectrometry results. Remaining serum, plasma, and urine is stored frozen for future research evaluation of other novel biomarkers for the diagnosis and prognosis of cancer.

After completion of study, patients are followed up periodically for approximately 5 years.

PROJECTED ACCRUAL: A total of 500 surgical patients, 100 cancer patients undergoing first-line therapy, and 40 disease-free women who are known BRCA-mutation carriers will be accrued for this study.


Study Design

Study Type : Observational
Actual Enrollment : 525 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of an Assay for the Early Detection of Ovarian Cancer.
Study Start Date : June 2009
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Biomarker testing
Collect serum for biomarker testing for LAP and HE4 and discovery of new biomarkers.
Diagnostic Test: Biomarker LPA and HE4
Non Interventional Trial


Outcome Measures

Primary Outcome Measures :
  1. Validation of a new assay for lysophosphatidic acid (LPA) [ Time Frame: 5 years ]
    To develop a serum or plasma based assay to quantitate LPA levels


Secondary Outcome Measures :
  1. Risk of finding ovarian cancer at the time of surgery in pre- and post-menopausal women [ Time Frame: 5 years ]
    To evaluate a quantitative serum LPA assay and correlate serum LPA levels in pre and post menopausal women with benign and malignant ovarian tumors.

  2. LPA results in pre- and post-menopausal women and women at high-risk of ovarian cancer [ Time Frame: 5 years ]
    To measure serum LPA levels in pre and postmenopausal women


Biospecimen Retention:   Samples Without DNA
Serum, Plasma, Urine

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women presenting with a pelvic mass and scheduled to undergo surgery.
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Presenting to a gynecological oncologist with a unilateral or bilateral pelvic mass (defined as a simple, complex, or a solid ovarian/pelvic mass) and scheduled to undergo surgery
    • Newly diagnosed epithelial ovarian cancer and undergoing first-line chemotherapy
    • History of epithelial ovarian carcinoma status post-primary chemotherapy treatment, currently in clinical remission according to the following criteria:

      • Absence of symptoms that may be related to disease
      • Imaging without abnormalities ≥ 1 cm suspicious for disease (no ascites)
      • CA125 obtained twice at least 3 weeks apart and not increasing by 50% and < 40 units/mL
    • Known BRCA mutations and intact ovaries (no prior bilateral salpingo-oophorectomy)
  • No synchronous primary endometrial cancer or a past history of primary endometrial cancer, 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
  • No epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
  • Patients of any stage who have recurred and are in second chemotherapy induced remission are not eligible

PATIENT CHARACTERISTICS:

  • Pre- or post-menopausal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other invasive malignancies within the past 5 years, with the exception of nonmelanoma skin cancer
  • No septicemia, severe infection, or acute hepatitis

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • No prior chemotherapy for another malignancy

Inclusion Criteria:

  • Eligible Patients
  • Patients age ≥ 21 years
  • Patients with a diagnosis of a pelvic mass (defined as a simple, complex or a solid ovarian / pelvic mass) who are scheduled to undergo surgery.
  • Patients with a new diagnosis of epithelial ovarian carcinoma undergoing primary chemotherapy treatment.
  • Patients with a history of epithelial ovarian carcinoma status post primary chemotherapy treatment, currently in clinical remission.
  • Patients with a known BRCA mutation and who have NOT undergone a bilateral salpingo-oophorectomy.
  • Clinical remission should require all of following:
  • Absence of symptoms that may be related to disease;
  • Imaging without abnormalities greater then or equal to 1 cm suspicious for disease (no ascites);
  • CA 125 obtained x 2 at least 3 weeks apart and not increasing by 50% and < 40 units/mL.
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information.
  • Women of childbearing potential must have a negative pregnancy test. They as well as their partners must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.

Exclusion Criteria:

  • Ineligible Patients
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. 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 I-B; 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.
  • Patients with epithelial ovarian carcinoma of low malignant potential (Borderline carcinomas).
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or have received chemotherapy for another malignancy.
  • Patients of any stage who have recurred and are in second chemotherapy induced remission.
  • Patients with septicemia, severe infection, or acute hepatitis.
  • Patients who are pregnant or lactating.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986206


Locations
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Richard G Moore, MD Women and Infants Hospital of Rhode Island
More Information

Responsible Party: Richard G. Moore, MD, Gynecologic Oncologist, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00986206     History of Changes
Other Study ID Numbers: WIHRI-09-0030
CDR0000655148 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 29, 2009    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Richard G. Moore, MD, Women and Infants Hospital of Rhode Island:
ovarian epithelial cancer
stage IA ovarian epithelial cancer
stage IB ovarian epithelial cancer
stage IC ovarian epithelial cancer
stage IIA ovarian epithelial cancer
stage IIB ovarian epithelial cancer
stage IIC ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer
stage IV ovarian epithelial cancer
BRCA1 mutation carrier
BRCA2 mutation carrier

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders