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

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ClinicalTrials.gov Identifier: NCT02321228
Recruitment Status : Active, not recruiting
First Posted : December 22, 2014
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen

Tracking Information
First Submitted Date  ICMJE December 11, 2014
First Posted Date  ICMJE December 22, 2014
Last Update Posted Date April 15, 2020
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
Menopause-related quality of life [ Time Frame: Up to 5 years after last surgery ]
Measured by the Greene Climacteric Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • General quality of life [ Time Frame: Up to 15 years after last surgery ]
    measured by several questionnaires
  • 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 ]
    Surgery-related complications
  • 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 ]
    i.e. waist-hip circumference, Fasting blood sample
  • Incidence of ovarian cancer [ Time Frame: Up to 15 years after last surgery ]
    Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)
  • Incidence of breast cancer [ Time Frame: Up to 15 years after last surgery ]
    Incidence of breast cancer
  • Cost-effectiveness of innovative preventive strategy [ Time Frame: 10 years after last surgery ]
    Costs per quality adjusted life year (QALY)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers
Official Title  ICMJE Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers
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.
Detailed Description Eligible women will choose for the innovative or standard risk-reducing option themselves.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Ovarian Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: Salpingectomy 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).
    Intervention: Procedure: Risk-reducing salpingo-oophorectomy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2014)
510
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2035
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02321228
Other Study ID Numbers  ICMJE NL50048.091.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
Study Sponsor  ICMJE University Medical Center Nijmegen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University Medical Center Nijmegen
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP