Evidence map›Paper›PMID 26286255›Full record

Trial reportBMC cancer2015

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.

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 and 10 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02321228 (Early Salpingectomy), which is not on this map. Cited by 48 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02321228 naactive not recruitingnot on this map

Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers

TypeinterventionalSponsorUniversity Medical Center NijmegenRan2015 to 2035Enrolled510ConditionsBRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian CancerArmsSalpingectomy with delayed oophorectomy, Risk-reducing salpingo-oophorectomy
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Recommendations for diagnosing STIC: a systematic review and meta-analysis.Virchows Archiv : an international journal of pathology · 2022
    Pooled it
  2. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Article
  6. Oncologic outcomes of incidental serous tubal intraepithelial carcinoma and associated high-grade serous carcinoma in high-risk patients undergoing risk-reducing surgery.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2026
    Article
  7. Observational
  8. Article
  9. Article
  10. Article
  11. High-Grade Serous Carcinoma at Risk-Reducing Salpingo-Oophorectomy in Asymptomatic Carriers ofJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Surgical decision making in premenopausalJournal of medical genetics · 2022
    Observational
  19. Article
  20. Pregnancy after breast cancer in BRCA1/2 mutation carriers.Hereditary cancer in clinical practice · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Marline G HarmsenDepartment of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Marline.Harmsen@radboudumc.nl.
Marieke Arts-de JongDepartment of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Marieke.Arts-deJong@radboudumc.nl.
Nicoline HoogerbruggeDepartment of Human Genetics, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Nicoline.Hoogerbrugge@radboudumc.nl.
Angela H E M MaasDepartment of Cardiology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Angela.Maas@radboudumc.nl.
Judith B PrinsDepartment of Medical Psychology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Judith.Prins@radboudumc.nl.
Johan BultenDepartment of Pathology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Hans.Bulten@radboudumc.nl.
Steven TeerenstraDepartment for Health Evidence, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Steven.Teerenstra@radboudumc.nl.
Eddy M M AdangDepartment for Health Evidence, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Eddy.Adang@radboudumc.nl.
Jurgen M J PiekGynaecologic Oncologic Center South location Elisabeth-TweeSteden Hospital, Dr. Deelenlaan 5, 5042 AD, Tilburg, The Netherlands. Jurgen.Piek@catharinaziekenhuis.nl.
Helena C van DoornDepartment of Gynaecology, Erasmus MC Cancer Clinic, 's-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. H.vanDoorn@erasmusmc.nl.
Marc van BeurdenCenter for Gynaecological Oncology Amsterdam (CGOA), Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. M.v.Beurden@nki.nl.
Marian J E MouritsDepartment of Gynaecology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands. M.J.E.Mourits@umcg.nl.
Ronald P ZweemerDepartment of Gynaecological Oncology, UMC Utrecht Cancer Centre, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. R.Zweemer@umcutrecht.nl.
Katja N GaarenstroomDepartment of Obstetrics and Gynaecology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands. K.N.Gaarenstroom@lumc.nl.
Brigitte F M SlangenDepartment of Obstetrics and Gynaecology, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX, Maastricht, The Netherlands. Brigitte.Slangen@mumc.nl.
M Caroline VosGynaecologic Oncologic Center South, Elisabeth-TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands. C.Vos@elisabeth.nl.
Luc R C W van LonkhuijzenCenter for Gynaecological Oncology Amsterdam (CGOA), AMC, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. L.R.vanLonkhuijzen@amc.uva.nl.
Leon F A G MassugerDepartment of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Leon.Massuger@radboudumc.nl.
Rosella P M G HermensScientific Institute for Quality of Healthcare, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Rosella.Hermens@radboudumc.nl.
Joanne A de HulluDepartment of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Joanne.deHullu@radboudumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRisk-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.

methodsA 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 registrationClinicalTrials.gov ( NCT02321228 ).

Indexed as

AdultBRCA1 ProteinBRCA2 ProteinCystadenocarcinoma, SerousFemaleGenetic Predisposition to DiseaseHumansIncidenceMenopause, PrematureMiddle AgedMutationOvarian NeoplasmsOvariectomyQuality of LifeSalpingectomyBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, human

Identifiers

PMID26286255
PMCPMC4541725

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.