Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers

NCT02321228 | Active Not Recruiting DMC

• 1 other identifier: NL50048.091.14
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.

Conditions

BRCA1 Gene Mutation; BRCA2 Gene Mutation; Ovarian Cancer

Keywords

Salpingectomy; Delayed oophorectomy; Salpingo-oophorectomy; Quality of life; Ovarian cancer; BRCA

Outcome Measures

Primary Outcomes (1)

• Menopause-related quality of life

  Measured by the Greene Climacteric Scale

  Up to 5 years after last surgery

Secondary Outcomes (9)

• General quality of life

  Up to 15 years after last surgery

• Quality of life related items

  Up to 15 years after last surgery

• Surgery-related complications

  6 weeks after each surgery

• Histopathologic findings of removed fallopian tubes and ovaries

  6 weeks after each surgery

• Cardiovascular risk factors

  Up to 5 years after last surgery

Study Arms (2)

Salpingectomy with delayed oophorectomy

EXPERIMENTAL

Female BRCA mutation carriers can opt for early salpingectomy upon completion of childbearing, followed by second stage oophorectomy delayed for five years beyond current guideline ages for risk-reducing salpingo-oophorectomy (i.e. age 40-45 for BRCA1 mutation carriers and 45-50 for BRCA mutation carriers).

Procedure: Salpingectomy with delayed oophorectomy

Risk-reducing salpingo-oophorectomy

ACTIVE COMPARATOR

Female BRCA mutation carriers can opt for standard risk-reducing salpingo-oophorectomy at current guideline ages (age 35-40 for BRCA1 mutation carriers and age 40-45 for BRCA2 mutation carriers).

Procedure: Risk-reducing salpingo-oophorectomy

Interventions

Salpingectomy with delayed oophorectomy PROCEDURE

Early salpingectomy upon completions of childbearing with postponement of oophorectomy until between 40 and 45 in BRCA1 mutation carriers and between age 45 and 50 in BRCA2 mutation carriers.

Also known as: Tubectomy with delayed oophorectomy

Salpingectomy with delayed oophorectomy

Risk-reducing salpingo-oophorectomy PROCEDURE

This is the current guideline procedure, usually performed between age 35 and 40 in BRCA1 mutation carriers and between age 40 and 45 in BRCA2 mutation carriers.

Also known as: Bilateral prophylactic salpingo-oophorectomy

Risk-reducing salpingo-oophorectomy

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women with a documented BRCA1 and/or BRCA2 germline mutation
• Age 25-40 years for BRCA1 mutation carriers, 25-45 years for BRCA2
• Childbearing completed
• Presence of at least one fallopian tube
• Participants may have a personal history of non-ovarian malignancy

You may not qualify if:

• Postmenopausal status (natural menopause or due to (cancer) treatment)
• Wish for second stage oophorectomy within two years after salpingectomy (if clear at enrollment)
• Legally incapable
• Prior bilateral salpingectomy
• A personal history of ovarian, fallopian tube or peritoneal cancer
• Evidence of malignant disease at enrollment
• Treatment for malignant disease at enrollment
• Inability to read or speak Dutch

Sponsors & Collaborators

• University Medical Center Nijmegen: lead

Study Sites (13)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, 5042 AD, Netherlands

Location

Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Academic Medical Center

Amsterdam, Netherlands

Location

VU University Medical center

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Medical Center

Leeuwarden, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Maxima Medical Center

Veldhoven, Netherlands

Location

Related Publications (3)

• van Bommel MHD, Steenbeek MP, IntHout J, Hermens RPMG, Hoogerbrugge N, Harmsen MG, van Doorn HC, Mourits MJE, van Beurden M, Zweemer RP, Gaarenstroom KN, Slangen BFM, Brood-van Zanten MMA, Vos MC, Piek JM, van Lonkhuijzen LRCW, Apperloo MJA, Coppus SFPJ, Prins JB, Custers JAE, de Hullu JA. Cancer worry among BRCA1/2 pathogenic variant carriers choosing surgery to prevent tubal/ovarian cancer: course over time and associated factors. Support Care Cancer. 2022 Apr;30(4):3409-3418. doi: 10.1007/s00520-021-06726-4. Epub 2022 Jan 8.

  PMID: 34997316 DERIVED

• Steenbeek MP, Harmsen MG, Hoogerbrugge N, de Jong MA, Maas AHEM, Prins JB, Bulten J, Teerenstra S, van Bommel MHD, van Doorn HC, Mourits MJE, van Beurden M, Zweemer RP, Gaarenstroom KN, Slangen BFM, Brood-van Zanten MMA, Vos MC, Piek JMJ, van Lonkhuijzen LRCW, Apperloo MJA, Coppus SFPJ, Massuger LFAG, IntHout J, Hermens RPMG, de Hullu JA. Association of Salpingectomy With Delayed Oophorectomy Versus Salpingo-oophorectomy With Quality of Life in BRCA1/2 Pathogenic Variant Carriers: A Nonrandomized Controlled Trial. JAMA Oncol. 2021 Aug 1;7(8):1203-1212. doi: 10.1001/jamaoncol.2021.1590.

  PMID: 34081085 DERIVED

• Harmsen MG, Arts-de Jong M, Hoogerbrugge N, Maas AH, Prins JB, Bulten J, Teerenstra S, Adang EM, Piek JM, van Doorn HC, van Beurden M, Mourits MJ, Zweemer RP, Gaarenstroom KN, Slangen BF, Vos MC, van Lonkhuijzen LR, Massuger LF, Hermens RP, de Hullu JA. Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study. BMC Cancer. 2015 Aug 19;15:593. doi: 10.1186/s12885-015-1597-y.

  PMID: 26286255 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Salpingectomy

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

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Joanne A de Hullu, MD, PhD

  University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

• Rosella PM Hermens, PhD

  Scientific Institute for Quality of Healtcare, UMCNijmegen

  PRINCIPAL INVESTIGATOR

• Nicoline Hoogerbrugge, MD, PhD

  University Medical Center Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, gynecologic oncologist, principal clinician

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 22, 2014
• Study Start: January 1, 2015
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

NL (13)