Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer

NCT00039559 | Unknown DMC

• 2 other identifiers: CDR0000069397MGH-000084
• Study Type: interventional
• Target: 2,430
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for ovarian cancer. PURPOSE: Screening trial to determine the significance of cancer antigen 125 (CA125) levels in detecting ovarian cancer in participants who have a high genetic risk of developing ovarian cancer.

Conditions

Ovarian Cancer

Keywords

ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity of early detection for ovarian cancer

  Up to one year since last blood test

Secondary Outcomes (1)

• Specificity of early detection

  Up to one year from last blood test

Study Arms (1)

Early detection

OTHER

Other: Early detection

Interventions

Early detection OTHER

CA125 is measured in blood and the longitudinal results interpreted with a statistical algorithm to determine if there has been a significant increase from baseline.

Early detection

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Participant meet the criteria for one of the following conditions: * Participant has tested positive for a mutation in the breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2) or has a first- or second-degree relative with a BRCA1 or BRCA2 mutation * At least 2 ovarian or breast cancers (including ductal carcinoma in situ) have occurred among the participant and her first- and second-degree relatives within the same lineage * Condition may be satisfied by multiple primary cancers in the same person * Where breast cancer is required to meet this criterion, at least 1 breast cancer patient must have been pre-menopausal (age 50 and under at diagnosis if age at menopause unknown) * Participant is of Ashkenazi Jewish ethnicity and either has had breast cancer or has 1 first-degree or 2 second-degree relatives with breast cancer (including ductal carcinoma in situ) or ovarian cancer * Where breast cancer is required to meet this criterion, at least 1 breast cancer patient must have been pre-menopausal (age 50 and under at diagnosis if age at menopause unknown) * Probability of carrying a BRCA1 or BRCA2 mutation exceeds 20% as calculated by BRCAPRO, given family pedigree of breast cancer (including ductal carcinoma in situ) and ovarian cancer * Participant must have no prior or concurrent ovarian cancer (including low malignant potential (LMP) cancers) or primary papillary serous carcinoma of the peritoneum * Participant must not be negative for the same BRCA1 or BRCA2 mutation for which a first- or second-degree relative has tested positive * Participants who test negative for BRCA1 or BRCA2 mutation are still eligible if the pedigree or BRCAPRO criteria are satisfied, including Ashkenazi women who test negative for the three founder mutations * Documentation of family history is by participant's self-report * In relatives, ovarian cancer is defined as invasive ovarian epithelial cancers, fallopian tube cancers, or primary papillary serous carcinoma of the peritoneum * Germ cell or granulosa tumors or LMP ovarian cancers do not qualify * First- and second-degree relatives include half siblings of the participant or her first-degree relative PATIENT CHARACTERISTICS: Age: * 30 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * No hemophilia or other bleeding disorders * No serious anemia Hepatic: * Not specified Renal: * Not specified Pulmonary: * No emphysema Other: * Not pregnant * Fertile patients must use effective contraception * No psychiatric, psychological, or other conditions that would preclude informed consent * No concurrent untreated malignancy except nonmelanoma skin cancer * No medical conditions that would preclude blood draws during study * No chronic infectious disease PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 months since prior adjuvant anticancer chemotherapy Endocrine therapy: * Prior or concurrent adjuvant hormonal therapies (e.g., tamoxifen, leuprolide, or goserelin) allowed * Concurrent hormonal therapies (e.g., tamoxifen) for prevention allowed Radiotherapy: * At least 3 months since prior adjuvant anticancer radiotherapy Surgery: * At least 3 months since prior intraperitoneal surgery (laparoscopy or laparotomy) * No prior prophylactic oophorectomy Other: * At least 5 years since prior non-hormonal treatment for metastatic malignancy * No concurrent participation in other ovarian cancer early detection trials

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Steven J. Skates, PhD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Steven Skates PhD

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: June 10, 2013

Record last verified: 2013-06

Locations

US (1)