Analyzing tumor tissue samples from patients with advanced ovarian cancer
Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
This study is trying to see if certain immune cells in tumor samples from patients with advanced ovarian cancer can help predict how long they will live without their cancer getting worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 174 (estimated) |
| Sex | Female |
| Sponsor | GOG Foundation Research network |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT01000259 on ClinicalTrials.gov |
What this trial studies
This research focuses on analyzing tumor tissue samples from patients who have undergone surgery for advanced stage III or IV ovarian epithelial cancer. The primary objective is to validate the ability of tumor-infiltrating lymphocytes (TILs) to predict progression-free survival and overall survival in patients based on the status of their debulked disease. The study utilizes previously collected tumor samples and employs laboratory techniques such as immunohistochemistry and double immunofluorescence assays to assess the presence of TILs. By understanding the role of TILs, the study aims to provide insights into patient responses to treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with stage III or IV ovarian epithelial cancer who have undergone surgery and have available tumor tissue samples.
Not a fit: Patients with early-stage ovarian cancer or those without available tumor tissue samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which patients are likely to benefit from specific treatments based on their tumor's immune profile.
How similar studies have performed: Other studies have shown promise in using tumor-infiltrating lymphocytes as biomarkers for predicting treatment outcomes, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: George Coukos — Gynecologic Oncology Group
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.