Quality-of-Life Assessment for Hereditary Breast and Ovarian Cancer Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hereditary Breast and Ovarian Cancer Syndrome+13 MoreQuality-of-Life Assessment - Other
Eligibility
30 - 50
Female
What conditions do you have?
Select

Study Summary

This trial compares two surgical procedures for preventing ovarian cancer in patients with genetic mutations.

Eligible Conditions
  • Hereditary Breast and Ovarian Cancer Syndrome
  • Deleterious MSH2 Gene Mutation
  • Deleterious BRIP1 Gene Mutation
  • Deleterious PALB2 Gene Mutation
  • Deleterious PMS2 Gene Mutation
  • Deleterious RAD51D Gene Mutation
  • Premenopausal
  • BRCA2 Gene Mutation
  • Deleterious EPCAM Gene Mutation
  • Deleterious MSH6 Gene Mutation
  • Deleterious RAD51C Gene Mutation
  • Deleterious MLH1 Gene Mutation
  • Deleterious BARD1 Gene Mutation
  • BRCA1 Gene Mutation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: From baseline to 6 months

Month 6
Percent of women with clinically meaningful change in the Female Sexual Function Index (FSFI) score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm II (RRSO)
1 of 2
Arm I (ISDO)
1 of 2

Active Control

Experimental Treatment

374 Total Participants · 2 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · N/A

Arm I (ISDO)Experimental Group · 4 Interventions: Quality-of-Life Assessment, Salpingectomy, Laboratory Biomarker Analysis, Oophorectomy · Intervention Types: Other, Procedure, Other, Procedure
Arm II (RRSO)ActiveComparator Group · 3 Interventions: Quality-of-Life Assessment, Salpingo-Oophorectomy, Laboratory Biomarker Analysis · Intervention Types: Other, Procedure, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salpingectomy
2011
Completed Phase 2
~670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 6 months

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,808 Previous Clinical Trials
1,790,117 Total Patients Enrolled
3 Trials studying Hereditary Breast and Ovarian Cancer Syndrome
275 Patients Enrolled for Hereditary Breast and Ovarian Cancer Syndrome
National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,483 Total Patients Enrolled
8 Trials studying Hereditary Breast and Ovarian Cancer Syndrome
30,993 Patients Enrolled for Hereditary Breast and Ovarian Cancer Syndrome
Karen H LuPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
4,000 Total Patients Enrolled

Eligibility Criteria

Age 30 - 50 · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Premenopausal women with a documented deleterious mutation in one of the following ovarian cancer genes are eligible for this study: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, or PMS2
Women who have had a different type of cancer in the past, such as breast or uterine cancer, are allowed to participate in this study as long as they are without any evidence of disease and are still premenopausal
The patient must have at least one fallopian tube and one ovary
to undergo a new sterilization procedure called Essure
The willingness of participants in the ISDO arm to return to the enrolling site for surgical procedures and care, including pre-operative and post-operative care, is a requirement for enrollment in the study.
The participant has the option to undergo two surgical procedures, one using the ISDO arm and the other using the control arm.