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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01000259
First received: October 22, 2009
Last updated: July 8, 2011
Last verified: June 2005

October 22, 2009
July 8, 2011
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Ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival of patients with suboptimally debulked disease or optimally debulked disease [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01000259 on ClinicalTrials.gov Archive Site
Ability of intratumoral TILs to predict overall survival of these 2 groups of patients [ Designated as safety issue: No ]
Same as current
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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

RATIONALE: 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.

PURPOSE: 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.

OBJECTIVES:

Primary

  • 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.
  • To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.

Secondary

  • To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.
  • 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.

Observational
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Ovarian Cancer
  • Other: fluorescent antibody technique
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
174
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DISEASE CHARACTERISTICS:

  • Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on 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 t he 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

PATIENT CHARACTERISTICS:

  • Demographic and follow-up data available

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Female
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01000259
CDR0000391277, GOG-8005
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: George Coukos, MD, PhD Abramson Cancer Center of the University of Pennsylvania
Investigator: Stephen C. Rubin, MD Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP