Actively Recruiting

FEMALE
ID01000259

Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer

Led by Gynecologic Oncology Group · Updated on 2017-05-05

174

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

G

Gynecologic Oncology Group

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying tumor tissue samples from patients who had surgery for advanced stage III or stage IV ovarian epithelial cancer. The study aims to see if tumor-infiltrating T lymphocytes (TILs) can help predict how long patients live without their cancer getting worse and their overall survival. This research may improve understanding of how the immune system affects treatment outcomes in ovarian cancer. The study uses previously collected tumor tissue samples from patients who had either optimal or suboptimal cytoreductive surgery. These samples are analyzed in the laboratory using immunohistochemistry and double immunofluorescence assays to detect TILs. Patients are grouped based on the extent of their surgery results to validate the predictive value of TILs for progression-free and overall survival. Participants have already undergone surgery and chemotherapy as part of other clinical trials, and their tissue samples and clinical data are used for analysis. Researchers review demographic, follow-up, and disease measurements to evaluate the role of TILs. The main outcomes studied are survival curves showing progression-free survival and overall survival. This observational study involves no new treatments or interventions for participants.

CONDITIONS

Brief Title

Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of stage III or IV ovarian epithelial cancer
  • Enrollment in Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial
  • Availability of fixed and paraffin-embedded tissue from primary surgery
  • Patients who had either optimal or suboptimal cytoreductive surgery
  • Adequate demographic and follow-up data collected
  • Measurable or nonmeasurable disease
  • Demographic and follow-up data available
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Time required to analyze samples

Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes (TIL) using immunohistochemistry and double immunofluorescence assays.

No additional visits required for sample analysis

Long-term Monitoring

Duration - Ongoing until study completion

Participants are followed over time to assess progression-free survival and overall survival based on tumor tissue analysis.

Follow-up visits as part of routine care

Trial Site Locations

Total: 1 location

1

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States, 19103

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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