Trials / Recruiting
RecruitingNCT01000259
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 174 (estimated)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVES: I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival (PFS) in patients with suboptimally debulked advanced stage III or IV ovarian epithelial cancer. II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease. SECONDARY OBJECTIVES: I. To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease. II. To validate the ability of intratumoral TILs to predict overall survival of patients with optimally debulked disease. OUTLINE: Patients are stratified according to status of debulked disease (suboptimal vs optimal). Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes (TIL) via immunohistochemistry and double immunofluorescence assays using standard immunostaining.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Laboratory Biomarker Analysis | Samples are analyzed in laboratory studies |
Timeline
- Start date
- 2004-09-01
- Primary completion
- 2100-01-01
- First posted
- 2009-10-23
- Last updated
- 2017-05-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01000259. Inclusion in this directory is not an endorsement.