NCT00897039

Brief Summary

RATIONALE: Collecting samples of tissue from patients with cancer to study in the laboratory may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs and plan the best treatment. PURPOSE: This laboratory study is looking at tumor tissue samples to predict response to chemotherapy in patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

September 20, 2013

Status Verified

July 1, 2009

First QC Date

May 9, 2009

Last Update Submit

September 19, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

ovarian serous cystadenocarcinomaovarian undifferentiated adenocarcinomarecurrent ovarian epithelial cancerovarian clear cell cystadenocarcinomaovarian endometrioid adenocarcinomaovarian mucinous cystadenocarcinomastage IA ovarian epithelial cancerstage IB ovarian epithelial cancerstage IC ovarian epithelial cancerstage IIA ovarian epithelial cancerstage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerrecurrent primary peritoneal cavity cancerstage IA primary peritoneal cavity cancerstage IB primary peritoneal cavity cancerstage IC primary peritoneal cavity cancerstage IIA primary peritoneal cavity cancerstage IIB primary peritoneal cavity cancerstage IIC primary peritoneal cavity cancerstage IIIA primary peritoneal cavity cancerstage IIIB primary peritoneal cavity cancerstage IIIC primary peritoneal cavity cancerrecurrent fallopian tube cancerstage IA fallopian tube cancerstage IB fallopian tube cancerstage IC fallopian tube cancerstage IIA fallopian tube cancerstage IIB fallopian tube cancerstage IIC fallopian tube cancerstage IIIA fallopian tube cancerstage IIIB fallopian tube cancerstage IIIC fallopian tube cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation of a statistically significant discriminator of sensitivity with complete response rate

Interventions

flow cytometryOTHER
immunohistochemistry staining methodOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Pathologically confirmed adenocarcinoma of 1 of the following types: * Ovarian * Primary peritoneal * Fallopian tube * Must meet 1 of the following criteria: * De novo malignancy with no prior chemotherapy * Advanced refractory malignancy with ≤ 2 standard chemotherapy treatment protocols * Tumor must be accessible for biopsy or drainage of effusions * Chemotherapy is considered a treatment option * No symptomatic or uncontrolled parenchymal brain metastases * No meningeal metastasis PATIENT CHARACTERISTICS: * Not pregnant * Negative pregnancy test * Fertile patients must agree to use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Southeastern Gynecologic Oncology, LLP - Northside

Atlanta, Georgia, 30342, United States

RECRUITING

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Flow CytometryImmunohistochemistry

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesHistocytochemistryHistological TechniquesImmunologic Techniques

Study Officials

  • Vladimir D. Kravtsov, MD

    Pierian Biosciences

    STUDY CHAIR

  • Matthew O. Burrell, MD

    Southeastern Gynecologic Oncology

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

March 1, 2006

Last Updated

September 20, 2013

Record last verified: 2009-07

Locations

US(1)