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Risk-reducing salpingectomy with delayed oophorectomy for BRCA2 Mutation (TUBA-WISP-II Trial)

N/A

Recruiting

Led By Karen H. Lu, MD, PhD

Research Sponsored by University Medical Center Nijmegen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until the age of 45 for brca1 and 50 for brca2 germline mutation carriers

Awards & highlights

TUBA-WISP-II Trial Summary

This trial aims to compare the effectiveness of removing the fallopian tubes first and delaying the removal of the ovaries as a way to reduce the risk of ovarian cancer in high-risk women.

Who is the study for?

This trial is for women aged 25-50 with a high-risk gene mutation (BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1) who have finished having children and still have at least one fallopian tube. Women with a history of non-ovarian cancer can join if they give informed consent.Check my eligibility

What is being tested?

The study compares two preventive surgeries in high-risk women: removing the fallopian tubes first and ovaries later versus removing both at once. The goal is to see if delaying ovary removal lowers ovarian cancer risk without immediate menopause.See study design

What are the potential side effects?

Potential side effects include surgical risks like bleeding and infection, early menopause symptoms after oophorectomy such as hot flashes and mood changes, and possible increased long-term health risks related to earlier menopause.

TUBA-WISP-II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until the age of 45 for brca1 and 50 for brca2 germline mutation carriers

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until the age of 45 for brca1 and 50 for brca2 germline mutation carriers

This trial's timeline: 3 weeks for screening, Varies for treatment, and until the age of 45 for brca1 and 50 for brca2 germline mutation carriers for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

High grade serous (ovarian) cancer incidence

Secondary outcome measures

Incidence of (pre)malignant findings in tubes/ovaries

Incidence of breast cancer

Incidence of pelvic cancer (other than ovarian cancer)

+2 more

Other outcome measures

High grade serous (ovarian) cancer incidence at the age of 70

TUBA-WISP-II Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Risk-reducing salpingectomy with delayed oophorectomyExperimental Treatment1 Intervention

Risk-reducing salpingectomy after the completion of childbearing with delayed oophorectomy.

Group II: Risk-reducing salpingo-oophorectomyActive Control1 Intervention

Risk-reducing salpingo-oophorectomy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Medical Center NijmegenLead Sponsor

47 Previous Clinical Trials

246,491 Total Patients Enrolled

Karen H. Lu, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

Rosella P.M.G. Hermens, MD,PhDPrincipal InvestigatorRadboud University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this medical study at present?

"As per clinicaltrials.gov, this current research trial is actively seeking eligible participants. The trial was first listed on 3/1/2020 and most recently updated on 4/15/2024."

Answered by AI

Are there several medical centers conducting this research study in North America?

"At present, this research investigation is seeking participants at 37 distinct locations. These sites are situated in major cities such as Katowice, Stockholm, and Melbourne, among others. Opting for the site closest to you is advised to reduce travel obligations upon enrollment."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, information available on clinicaltrials.gov indicates that this research study is currently in the recruitment phase. The trial was initially posted on March 1st, 2020 and last modified on April 15th, 2024. Recruitment aims to enroll a total of 3000 participants distributed across 37 different sites."

Answered by AI

Are individuals above the age of 85 being sought for participation in this study?

"Eligible candidates for this research project are individuals aged between 25 and 50 years. Notably, there are 18 trials catering to participants under the age of 18 and another 398 targeting those above the age of 65."

Answered by AI

Which individuals are eligible to take part in this clinical trial?

"The research study aims to recruit 3000 individuals aged between 25 and 50 who currently carry the BRCA2 gene mutation. Specifically, eligible participants should meet the subsequent conditions: Female patients with a definitive pathogenic (Class 5) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 inherited mutation at one of the collaborating centers., Age requirements include: BRCA1 - between 25 and 40 years old; BRCA2 - between 25 and 45 years old; RAD51C, RAD51D, BRIP1 - between 25 and up to 50 years"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

Joanne A. de Hullu, MD, PhD 2020. "TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294927.