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

Primary Purpose

BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Cancer

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Salpingectomy with delayed oophorectomy
Risk-reducing salpingo-oophorectomy
Sponsored by
University Medical Center Nijmegen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for BRCA1 Gene Mutation focused on measuring Salpingectomy, Delayed oophorectomy, Salpingo-oophorectomy, Quality of life, Ovarian cancer, BRCA

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University Medical Center
  • Catharina Hospital
  • Elisabeth-TweeSteden Hospital
  • Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
  • Leiden University Medical Center
  • Erasmus Medical Center
  • Academic Medical Center
  • VU University Medical center
  • University Medical Center Groningen
  • Medical Center
  • Radboudumc
  • University Medical Center Utrecht
  • Maxima Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Salpingectomy with delayed oophorectomy

Risk-reducing salpingo-oophorectomy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Menopause-related quality of life
Measured by the Greene Climacteric Scale

Secondary Outcome Measures

General quality of life
measured by several questionnaires
Quality of life related items
i.e. sexual functioning, cancer worry, satisfaction with decision
Surgery-related complications
Surgery-related complications
Histopathologic findings of removed fallopian tubes and ovaries
- Histopathologic findings of removed fallopian tubes and ovaries
Cardiovascular risk factors
Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases
Incidence of cardiovascular diseases
i.e. waist-hip circumference, Fasting blood sample
Incidence of ovarian cancer
Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)
Incidence of breast cancer
Incidence of breast cancer
Cost-effectiveness of innovative preventive strategy
Costs per quality adjusted life year (QALY)

Full Information

First Posted
December 11, 2014
Last Updated
May 17, 2022
Sponsor
University Medical Center Nijmegen
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1. Study Identification

Unique Protocol Identification Number
NCT02321228
Brief Title
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers
Acronym
TUBA
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Nijmegen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Cancer
Keywords
Salpingectomy, Delayed oophorectomy, Salpingo-oophorectomy, Quality of life, Ovarian cancer, BRCA

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Salpingectomy with delayed oophorectomy
Arm Type
Experimental
Arm Description
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).
Arm Title
Risk-reducing salpingo-oophorectomy
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Salpingectomy with delayed oophorectomy
Other Intervention Name(s)
Tubectomy with delayed oophorectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Risk-reducing salpingo-oophorectomy
Other Intervention Name(s)
Bilateral prophylactic salpingo-oophorectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Menopause-related quality of life
Description
Measured by the Greene Climacteric Scale
Time Frame
Up to 5 years after last surgery
Secondary Outcome Measure Information:
Title
General quality of life
Description
measured by several questionnaires
Time Frame
Up to 15 years after last surgery
Title
Quality of life related items
Description
i.e. sexual functioning, cancer worry, satisfaction with decision
Time Frame
Up to 15 years after last surgery
Title
Surgery-related complications
Description
Surgery-related complications
Time Frame
6 weeks after each surgery
Title
Histopathologic findings of removed fallopian tubes and ovaries
Description
- Histopathologic findings of removed fallopian tubes and ovaries
Time Frame
6 weeks after each surgery
Title
Cardiovascular risk factors
Description
Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases
Time Frame
Up to 5 years after last surgery
Title
Incidence of cardiovascular diseases
Description
i.e. waist-hip circumference, Fasting blood sample
Time Frame
Up to 15 years after last surgery
Title
Incidence of ovarian cancer
Description
Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)
Time Frame
Up to 15 years after last surgery
Title
Incidence of breast cancer
Description
Incidence of breast cancer
Time Frame
Up to 15 years after last surgery
Title
Cost-effectiveness of innovative preventive strategy
Description
Costs per quality adjusted life year (QALY)
Time Frame
10 years after last surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne A de Hullu, MD, PhD
Organizational Affiliation
University Medical Center Nijmegen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosella PM Hermens, PhD
Organizational Affiliation
Scientific Institute for Quality of Healtcare, UMCNijmegen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicoline Hoogerbrugge, MD, PhD
Organizational Affiliation
University Medical Center Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Elisabeth-TweeSteden Hospital
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
VU University Medical center
City
Amsterdam
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medical Center
City
Leeuwarden
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Maxima Medical Center
City
Veldhoven
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34997316
Citation
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.
Results Reference
derived
PubMed Identifier
34081085
Citation
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.
Results Reference
derived
PubMed Identifier
26286255
Citation
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.
Results Reference
derived

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

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