Recruiting

Observational Study

Sponsor:

Gynecologic Oncology Group

Code:

NCT01000259

Conditions

Stage IIIA Ovarian Cancer

Stage IIIB Ovarian Cancer

Stage IIIC Ovarian Cancer

Stage IV Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Laboratory Biomarker Analysis

Study Details

Brief summary:

This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment.

Conditions

Stage IIIA Ovarian Cancer

Stage IIIB Ovarian Cancer

Stage IIIC Ovarian Cancer

Stage IV Ovarian Cancer

Study ID

NCT01000259

Start date

Sep, 2004

Status verified date

May, 2017

Primary completion date

Jan, 2100

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial (GOG-0114, GOG-132, GOG-0158, or GOG-0162)
  • Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of the following sources:

  • Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)
  • Patients who have had either optimal or suboptimal cytoreductive surgery
  • Patients for whom adequate demographic data, including major prognostic factors and follow-up information, were collected
  • Evaluable patients must have had measurable or nonmeasurable disease
  • Demographic and follow-up data available

Study Design

Enrollment

174 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-Correlative

Previously collected tumor tissue samples are analyzed for TIL via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Interventions

Laboratory Biomarker Analysis

Samples are analyzed in laboratory studies

Primary outcome measure

  • Overall survival curves [ Time Frame: Baseline ]
  • Progression-free survival curves [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Gynecologic Oncology Group

Recruiting

Philadelphia, Pennsylvania, United States, 19103

Contacts

George Coukos

215-662-3316gcoukos@mail.obgyn.upenn.edu

Principal Investigator:

George Coukos

More Information

Sponsor

Gynecologic Oncology Group

Last update posted

May 5, 2017

Last verified

May, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Gynecologic Oncology Group on 2017-05-05.