Suspended

Molecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer: A Controlled Pilot Study in Ovarian Cancer Chemoprevention

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What is being tested

celecoxib

+ oophorectomy

DrugProcedure
Who is being recruted

Carcinoma, Ovarian Epithelial+16

+ Urogenital Diseases

+ Genital Diseases

Over 19 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: June 2002
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2002

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Compare histologic and molecular alterations in tissue biomarkers of patients at high risk for ovarian cancer treated with celecoxib followed by prophylactic oophorectomy vs prophylactic oophorectomy only. Secondary * Compare alterations in gene expression pattern in patients treated with these regimens. OUTLINE: This is a pilot study. Patients are assigned to 1 of 2 treatment groups. * Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy. * Group II: Patients undergo immediate prophylactic oophorectomy.

Official TitleMolecular Alterations in Human Ovarian Epithelium Induced by Chemopreventive Agents in Patients at Elevated Inherited Risk of Ovarian Cancer: A Controlled Pilot Study in Ovarian Cancer Chemoprevention
NCT00084370
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Carcinoma, Ovarian EpithelialUrogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesOvarian NeoplasmsUrogenital NeoplasmsFemale Urogenital Diseases

Criteria

DISEASE CHARACTERISTICS: * At high risk for ovarian cancer and meets criteria for 1 of the following: * Family history of at least 2 ovarian\*\* or breast cancers\* among the patient and first- or second-degree relatives in the same lineage * Multiple primary cancers in the same person may fulfill this requirement * Ashkenazi Jewish ethnicity AND 1 first-degree or 2 second-degree relatives with breast\* or ovarian\*\* cancer * Ashkenazi Jewish ethnicity AND had prior breast cancer\* * BRCA1/BRCA2 mutation probability \> 20% by BRCAPRO * Positive for BRCA1 or BRCA2 mutation * First- or second-degree relative with a BRCA1/BRCA2 mutation NOTE: \*At least 1 breast cancer must be premenopausal (diagnosed at age 50 or under if menopausal status unknown); ductal carcinoma in situ qualifies as breast cancer NOTE: \*\*In relatives, only ovarian epithelial cancer, fallopian tube cancer, and primary papillary serous cancer qualifies as ovarian cancer * No prior or concurrent ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum * No clinical evidence of ovarian cancer by physical examination, CA 125 evaluation, and pelvic ultrasound PATIENT CHARACTERISTICS: Age * 19 and over Performance status * GOG 0-1 Life expectancy * Not specified Hematopoietic * WBC \> 3,000/mm\^3 * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * No hemophilia or other bleeding disorder * No serious anemia Hepatic * Transaminases normal * Bilirubin normal Renal * Creatinine clearance \> 80 mL/min OR * Creatinine \< 2.0 mg/dL Pulmonary * No emphysema Other * Not pregnant or nursing * No psychiatric or psychological condition that would preclude giving informed consent * No concurrent untreated malignancy except nonmelanoma skin cancer * No other medical condition that would preclude blood draws (e.g., chronic infectious disease) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 3 months since prior adjuvant chemotherapy Endocrine therapy * Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed Radiotherapy * More than 3 months since prior adjuvant radiotherapy Surgery * More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy) * No prior oophorectomy Other * More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy * No concurrent participation in other ovarian cancer early detection clinical trials

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group I: Patients receive oral celecoxib twice daily for 3 months and then undergo prophylactic oophorectomy.

Group II

Experimental
Group II: Patients undergo immediate prophylactic oophorectomy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps
SuspendedOne Study Center