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Trial record 1 of 1 for:    GOG 0271
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Biomarkers in Patients With Previously Untreated Invasive Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01295489
First received: February 11, 2011
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
This research trial studies biomarkers in patients with previously untreated invasive ovarian epithelial, fallopian tube, or primary peritoneal cancer. Studying samples of tumor tissue, peritoneal cavity fluid, and blood from patients receiving chemotherapy directly into the abdominal cavity (intraperitoneal) may help doctors learn more about the effects of intraperitoneal chemotherapy on cells. It may also help doctors identify and learn more about biomarkers related to cancer.

Condition Intervention
Fallopian Tube Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Other: Laboratory Biomarker Analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Local and Systemic Effects of Intraperitoneal Chemotherapy in the Treatment of Previously-Untreated, Invasive Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Amount of peritoneal fluid obtained during each attempted extraction of peritoneal fluid or washing [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Presence of immune cells measured by immunohistochemistry in archival formalin-fixed, paraffin-embedded tumor tissue [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The staining intensities of immune cells detected in immunohistochemically stained paraffin tissue will be described using descriptive statistics such as the median, 1st and 3rd quartiles of staining intensities. Spearman's correlation coefficient will be used to assess associations between these intensities and the cell counts obtained from pre-treatment peripheral blood and peritoneal fluids. Boxplots or scattergrams will be used to display these data.

  • Quantity of each type of immune cells identified in the peritoneal fluid or washings specimens [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    A Wilcoxon signed rank test will be used to evaluate the null hypothesis that the expectation of the pretreatment cell counts is equal to the expectation of the post-treatment cell count. Descriptive statistics such as the mean, variance, median, 1st and 3rd quartiles as well as the spearman correlation between pre- and post- treatment cell counts will be reported for each cell type. Boxplots or scattergrams will be used to display the results. The mean, variance and quartiles of the amount of fluid recovered from pre-treatment and post-treatment samples will also be reported.

  • Quantity of each type of mononuclear cells in peripheral blood [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The number and type of mononuclear cells in peripheral blood will be described using descriptive statistics such as the median, 1st and 3rd quartiles. Spearman's correlation coefficient will be used to assess associations between pre- and post- treatment values. Boxplots or scattergrams will be used to display these data. A Wilcoxon signed rank test, that involves the patients' pre- and post- treatment measurements, will be used to evaluate the null hypothesis that these cell counts are unchanged by treatment.


Estimated Enrollment: 39
Study Start Date: March 2011
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A (IP catheter removed)
Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and blood (for cell, plasma, and serum isolations) is collected before courses two and three for translational research.
Other: Laboratory Biomarker Analysis
Correlative studies
Group B (IP catheter in place)
Archival formalin-fixed, paraffin-embedded tumor (collected during previous surgery), peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolation) samples are collected before course one and peritoneal fluid, peritoneal wash, and blood (for cell, plasma, and serum isolations) before courses two and three for translational research.
Other: Laboratory Biomarker Analysis
Correlative studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with previously untreated invasive ovarian epithelial, fallopian tube, or primary peritoneal cancer
Criteria

Inclusion Criteria:

  • Patients must be enrolled on GOG-0252
  • Patients must have an IP catheter placed prior to initiating platinum and taxane-based chemotherapy on GOG-0252
  • Patients must have signed an approved informed consent for specimen collection and participation in this translational research study

Exclusion Criteria:

  • Patients who are not enrolled on GOG-0252
  • Patients who have not had an IP catheter placed prior to initiating platinum and taxane-based IP chemotherapy on GOG-0252
  • Patients who did not sign an approved informed consent for specimen collection and participation in this translational research study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295489

Locations
United States, Illinois
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Memorial Medical Center
Springfield, Illinois, United States, 62781
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59107
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
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, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Robert Edwards NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01295489     History of Changes
Other Study ID Numbers: GOG-0271  NCI-2011-02871  CDR0000695260  GOG-0271  GOG-0271  U10CA180868  U10CA027469 
Study First Received: February 11, 2011
Last Updated: March 16, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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

ClinicalTrials.gov processed this record on December 09, 2016