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Trial record 3 of 34 for:    salpingectomy

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University Medical Center Nijmegen
Sponsor:
Information provided by (Responsible Party):
Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT02321228
First received: December 11, 2014
Last updated: August 22, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ovarian Cancer
Procedure: Salpingectomy with delayed oophorectomy
Procedure: Risk-reducing salpingo-oophorectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers

Resource links provided by NLM:


Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • Menopause-related quality of life [ Time Frame: Up to 5 years after last surgery ]
    Measured by the Greene Climacteric Scale


Secondary Outcome Measures:
  • General quality of life [ Time Frame: Up to 15 years after last surgery ]
  • Quality of life related items [ Time Frame: Up to 15 years after last surgery ]
    i.e. sexual functioning, cancer worry, satisfaction with decision

  • Surgery-related complications [ Time Frame: 6 weeks after each surgery ]
  • Histopathologic findings of removed fallopian tubes and ovaries [ Time Frame: 6 weeks after each surgery ]
    - Histopathologic findings of removed fallopian tubes and ovaries

  • Cardiovascular risk factors [ Time Frame: Up to 5 years after last surgery ]
    Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases

  • Incidence of cardiovascular diseases [ Time Frame: Up to 15 years after last surgery ]
  • Incidence of ovarian cancer [ Time Frame: Up to 15 years after last surgery ]
  • Incidence of breast cancer [ Time Frame: Up to 15 years after last surgery ]
  • Cost-effectiveness of innovative preventive strategy [ Time Frame: 10 years after last surgery ]
    Costs per quality adjusted life year (QALY)


Estimated Enrollment: 510
Study Start Date: January 2015
Estimated Study Completion Date: January 2035
Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salpingectomy with delayed oophorectomy
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
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.
Other Name: Tubectomy with delayed oophorectomy
Active Comparator: Risk-reducing salpingo-oophorectomy
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
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.
Other Name: Bilateral prophylactic salpingo-oophorectomy

Detailed Description:
Eligible women will choose for the innovative or standard risk-reducing option themselves.
  Eligibility

Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

BRCA mutation carriers who opt for salpingectomy but who do not want to postpone the oophorectomy beyond the guideline age will undergo similar follow-up but do not contribute to the 510 inclusions we need

  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: NCT02321228

Contacts
Contact: Marline G Harmsen, MD +31 (0) 24 36 66455 Marline.Harmsen@Radboudumc.nl
Contact: Joanne A de Hullu, MD, PhD +31 (0) 24 36 16683 Joanne.deHullu@Radboudumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Brigitte FM Slangen, MD, PhD       Brigitte.Slangen@mumc.nl   
Catharina Hospital Recruiting
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Contact: Jurgen MJ Piek, MD, PhD       jurgen.piek@catharina-ziekenhuis.nl   
Elisabeth-TweeSteden Hospital Recruiting
Tilburg, Noord-Brabant, Netherlands, 5042 AD
Contact: M C Vos, MD       c.vos@elisabeth.nl   
Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Contact: Marc van Beurden, MD, PhD       M.v.Beurden@nki.nl   
Leiden University Medical Center Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: Katja N Gaarenstroom, MD, PhD       K.N.Gaarenstroom@lumc.nl   
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3015 CE
Contact: Helena C van Doorn, MD, PhD       H.vanDoorn@erasmusmc.nl   
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: Luc RCW van Lonkhuijzen, MD, PhD       l.r.vanlonkhuijzen@amc.uva.nl   
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Marian JE Mourits, MD, PhD       M.J.E.Mourits@umcg.nl   
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: Joanne A de Hullu, MD PhD       joanne.dehullu@radboudumc.nl   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Ronald P Zweemer, MD, PhD       R.Zweemer@umcutrecht.nl   
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
Principal Investigator: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joanne A. de Hullu, MD, PhD, MD, PhD, gynecologic oncologist, principal clinician, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT02321228     History of Changes
Other Study ID Numbers: NL50048.091.14
Study First Received: December 11, 2014
Last Updated: August 22, 2016

Keywords provided by University Medical Center Nijmegen:
Salpingectomy
Delayed oophorectomy
Salpingo-oophorectomy
Quality of life
Ovarian cancer
BRCA

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 March 28, 2017