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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04294927




Registration number
NCT04294927
Ethics application status
Date submitted
1/03/2020
Date registered
4/03/2020

Titles & IDs
Public title
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
Scientific title
TUBectomy With Delayed Oophorectomy as Alternative for Risk-reducing Salpingo-oophorectomy in High Risk Women to Assess the Safety of Prevention: TUBA-WISP II Study.
Secondary ID [1] 0 0
NL 70691.091.19
Universal Trial Number (UTN)
Trial acronym
TUBA-WISP-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BRCA1 Gene Mutation 0 0
BRCA2 Gene Mutation 0 0
RAD51C Gene Mutation 0 0
RAD51D Gene Mutation 0 0
BRIP1 Gene Mutation 0 0
Ovarian Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Risk-reducing salpingectomy with delayed oophorectomy
Treatment: Surgery - Risk-reducing salpingo-oophorectomy

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

Active comparator: Risk-reducing salpingo-oophorectomy - Risk-reducing salpingo-oophorectomy.


Treatment: Surgery: Risk-reducing salpingectomy with delayed oophorectomy
* BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45).
* BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50).
* BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)

Treatment: Surgery: Risk-reducing salpingo-oophorectomy
* BRCA1 at a maximum age of 40 (advised between age 35 and 40)
* BRCA2 at a maximum age of 45 (advised between age 40 and 45)
* BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
High grade serous (ovarian) cancer incidence
Timepoint [1] 0 0
Until the age of 45 for BRCA1 and 50 for BRCA2 germline mutation carriers
Secondary outcome [1] 0 0
Incidence of (pre)malignant findings in tubes/ovaries
Timepoint [1] 0 0
6 weeks after each surgery
Secondary outcome [2] 0 0
Peri-operative morbidity and mortality
Timepoint [2] 0 0
6 weeks after each surgery
Secondary outcome [3] 0 0
Incidence of pelvic cancer (other than ovarian cancer)
Timepoint [3] 0 0
Up to the age of 70
Secondary outcome [4] 0 0
Incidence of breast cancer
Timepoint [4] 0 0
Up to the age of 70
Secondary outcome [5] 0 0
Uptake of risk reducing oophorectomy
Timepoint [5] 0 0
Up to the age of 70

Eligibility
Key inclusion criteria
* Women with a class 5 (definitely pathogenic) BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation in one of the participating centers.
* Age at inclusion;

* BRCA1: 25-40 years
* BRCA2: 25-45 years
* RAD51C, RAD51D, BRIP1: 25-50 years
* Childbearing completed
* Presence of at least one fallopian tube
* Participants may have a personal history of non-ovarian malignancy
* Informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution.
Minimum age
25 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Postmenopausal status (natural menopause or due to treatment)
* Wish for second stage RRO within two years after RRS
* Legally incapable
* Prior bilateral salpingectomy
* A personal history of ovarian, fallopian tube or peritoneal cancer
* Current diagnosis or treatment for malignant disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/02/2040
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Melbourne
Recruitment hospital [2] 0 0
Peter MacCallum Centre - Melbourne
Recruitment hospital [3] 0 0
Royal Womens Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussel
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Brazil
State/province [7] 0 0
São Paulo
Country [8] 0 0
Italy
State/province [8] 0 0
Bologna
Country [9] 0 0
Italy
State/province [9] 0 0
Monza
Country [10] 0 0
Italy
State/province [10] 0 0
Rome
Country [11] 0 0
Mexico
State/province [11] 0 0
Mexico City
Country [12] 0 0
Netherlands
State/province [12] 0 0
Brabant
Country [13] 0 0
Netherlands
State/province [13] 0 0
Gelderland
Country [14] 0 0
Netherlands
State/province [14] 0 0
Limburg
Country [15] 0 0
Netherlands
State/province [15] 0 0
Noord-Brabant
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Netherlands
State/province [17] 0 0
Enschede
Country [18] 0 0
Netherlands
State/province [18] 0 0
Groningen
Country [19] 0 0
Netherlands
State/province [19] 0 0
Leeuwarden
Country [20] 0 0
Netherlands
State/province [20] 0 0
Leiden
Country [21] 0 0
Netherlands
State/province [21] 0 0
Rotterdam
Country [22] 0 0
Netherlands
State/province [22] 0 0
Utrecht
Country [23] 0 0
Netherlands
State/province [23] 0 0
Veldhoven
Country [24] 0 0
Netherlands
State/province [24] 0 0
Zwolle
Country [25] 0 0
Norway
State/province [25] 0 0
Nordbyhagen
Country [26] 0 0
Norway
State/province [26] 0 0
Oslo
Country [27] 0 0
Norway
State/province [27] 0 0
Stavanger
Country [28] 0 0
Poland
State/province [28] 0 0
Gdynia
Country [29] 0 0
Poland
State/province [29] 0 0
Katowice
Country [30] 0 0
Poland
State/province [30] 0 0
Warsaw
Country [31] 0 0
Sweden
State/province [31] 0 0
Stockholm
Country [32] 0 0
Uruguay
State/province [32] 0 0
Montevideo

Funding & Sponsors
Primary sponsor type
Other
Name
University Medical Center Nijmegen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne A. de Hullu, MD, PhD
Address 0 0
Radboud University Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joanne A. de Hullu, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+31 (0) 24 36 16683
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04294927