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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Skates, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00039559
First received: June 6, 2002
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Ovarian Cancer
Other: Early detection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Ovarian Cancer Screening Pilot Trial in High Risk Women

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Sensitivity of early detection for ovarian cancer [ Time Frame: Up to one year since last blood test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specificity of early detection [ Time Frame: Up to one year from last blood test ] [ Designated as safety issue: No ]

Estimated Enrollment: 2430
Study Start Date: May 2002
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early detection Other: Early detection
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039559

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Study Chair: Steven J. Skates, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Skates, Steven Skates PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00039559     History of Changes
Obsolete Identifiers: NCT00301743
Other Study ID Numbers: CDR0000069397, MGH-000084
Study First Received: June 6, 2002
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 22, 2014