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BMC Cancer
Published in: BMC Cancer 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Marline G. Harmsen, Marieke Arts-de Jong, Nicoline Hoogerbrugge, Angela H. E. M. Maas, Judith B. Prins, Johan Bulten, Steven Teerenstra, Eddy M. M. Adang, Jurgen M. J. Piek, Helena C van Doorn, Marc van Beurden, Marian J. E. Mourits, Ronald P. Zweemer, Katja N. Gaarenstroom, Brigitte F. M. Slangen, M. Caroline Vos, Luc R. C. W. van Lonkhuijzen, Leon F. A. G. Massuger, Rosella P. M. G. Hermens, Joanne A. de Hullu

Published in: BMC Cancer | Issue 1/2015

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Abstract

Background

Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80–96 % but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated.

Methods

A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35–40 (BRCA1) or 40–45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40–45 (BRCA1) or 45–50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed.

Discussion

The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL.

Trial registration

ClinicalTrials.gov (NCT02321228)
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Metadata
Title
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
Authors
Marline G. Harmsen
Marieke Arts-de Jong
Nicoline Hoogerbrugge
Angela H. E. M. Maas
Judith B. Prins
Johan Bulten
Steven Teerenstra
Eddy M. M. Adang
Jurgen M. J. Piek
Helena C van Doorn
Marc van Beurden
Marian J. E. Mourits
Ronald P. Zweemer
Katja N. Gaarenstroom
Brigitte F. M. Slangen
M. Caroline Vos
Luc R. C. W. van Lonkhuijzen
Leon F. A. G. Massuger
Rosella P. M. G. Hermens
Joanne A. de Hullu
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2015
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-015-1597-y

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