Suspended

Specialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Carcinoma, Ovarian Epithelial
+16

+ Urogenital Diseases
+ Genital Diseases
Over 30 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2003
See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2003Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the feasibility of prospective screening for ovarian cancer in high-risk patients. * Determine normal ranges and distributions of CA 125 within and between these patients (with subclassification by menopausal status, estrogen replacement therapy usage, and prophylactic oophorectomy). Secondary * Determine estimates of the specificity and positive predictive value of a risk of cancer algorithm suitable for designing a definitive trial of screening for ovarian cancer in these patients. OUTLINE: This is a multicenter, pilot study. Patients undergo blood collection and CA 125 levels are measured at baseline and then every 3 months for 1-2 years. Patients may be referred for an ovarian ultrasound if indicated by the CA 125 results. Patients are followed at 6 months and then annually thereafter. PROJECTED ACCRUAL: A total of 2,400 patients will be accrued for this study within 1 year.

Official TitleSpecialized Program Of Research Excellence (SPORE) In Ovarian Cancer/Cancer Genetics Network Collaborative Ovarian Cancer Screening Pilot Trial In High Risk Women 
NCT00080639
Principal SponsorUniversity of Alabama at Birmingham
Last updated: January 13, 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.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.

Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 30 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Carcinoma, Ovarian Epithelial
Urogenital Diseases
Genital Diseases
Adnexal Diseases
Carcinoma
Endocrine System Diseases
Endocrine Gland Neoplasms
Female Urogenital Diseases and Pregnancy Complications
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Ovarian Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Criteria

DISEASE CHARACTERISTICS: * At high risk for developing ovarian cancer, as determined by meeting criteria for 1 of the following: * Family history of at least 2 ovarian or breast\* cancers among the patient and first- and second-degree relatives within the same lineage\*\* * If breast cancer\* is required to meet this criterion, at least 1 breast cancer\* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown) NOTE: \*\*Multiple primary cancers in the same person satisfies this criterion * Ashkenazi Jewish ethnicity and meets criteria for 1 of the following: * Prior breast cancer\* diagnosis * One first-degree or 2 second-degree relatives with breast\* or ovarian cancer * If breast cancer is required to meet this criterion, at least 1 breast cancer\* must be premenopausal (diagnosed at age 50 or under if menopausal status unknown) * Probability of BRCA1 or BRCA2 mutation greater than 20%, as determined by BRCAPRO 95% posterior probability interval * This criterion includes the following situations for which BRCAPRO is not required: * Tested positive for a BRCA1 or BRCA2 mutation (100% probability) * First- or second-degree relative with a BRCA1 or BRCA2 mutation NOTE: \*Including ductal carcinoma in situ * No ovarian cancer, including low malignant potential cancers or primary papillary serous carcinoma of the peritoneum PATIENT CHARACTERISTICS: Age * 30 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * No hemophilia * No other bleeding disorders Hepatic * Not specified Renal * Not specified Pulmonary * No emphysema Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * 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 for cancer Endocrine therapy * Concurrent adjuvant hormonal therapy (e.g., tamoxifen, leuprolide, or goserelin) allowed Radiotherapy * More than 3 months since prior adjuvant radiotherapy for cancer Surgery * More than 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy) * Prior prophylactic oophorectomy allowed Other * More than 5 years since prior treatment (excluding hormonal therapy) for metastatic malignancy * No concurrent participation in other ovarian cancer early detection trials

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
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
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, United StatesSee the location
SuspendedOne Study Center