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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.

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 - BMC Cancer (2015)

Bottom Line: The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Marline.Harmsen@radboudumc.nl.

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 ).

No MeSH data available.


Related in: MedlinePlus

Schedule of follow-up in TUBA study
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Fig2: Schedule of follow-up in TUBA study

Mentions: Six weeks after surgery, data on surgical complications and histopathological findings are collected. The Sectioning and Extensively Examining the FIMbriated End (SEE-FIM) of the Fallopian Tube (SEE-FIM) protocol will be used for the latter [64]. Follow-up by web-based questionnaires as described at baseline except for the Decisional Conflict Scale is scheduled at 3 and 12 months after surgery. At 1, 5 and 15 years follow-up, the Decision Regret Scale (DRS) is added [65]. From one year after surgery, questionnaires will be sent biennially until the end of follow-up (in case of only one surgery in the standard treatment arm) or until undergoing RRO (in the innovative arm). After RRO, data will be collected at six weeks and 3 and 12 months after surgery, comparable to follow-up after the first operation, and then biennial questionnaires will be sent until the end of follow-up, 15 years after the last (or only) surgery. Additionally, blood pressure, body mass index, waist-hip ratio and cardiovascular risk factors in fasting blood samples will be collected five years after each surgery. Follow-up by questionnaires will continue biennially until 15 years after the last surgery to detect occurrence of ovarian cancer. Since the wide possible range of age at inclusion, timing of surgeries and interval between surgeries, it is hard to specify and generalize the exact amount and timing of follow-up. A flowchart visualising the follow-up schedule can be found in Fig. 2.Fig. 2


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.

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 - BMC Cancer (2015)

Schedule of follow-up in TUBA study
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4541725&req=5

Fig2: Schedule of follow-up in TUBA study
Mentions: Six weeks after surgery, data on surgical complications and histopathological findings are collected. The Sectioning and Extensively Examining the FIMbriated End (SEE-FIM) of the Fallopian Tube (SEE-FIM) protocol will be used for the latter [64]. Follow-up by web-based questionnaires as described at baseline except for the Decisional Conflict Scale is scheduled at 3 and 12 months after surgery. At 1, 5 and 15 years follow-up, the Decision Regret Scale (DRS) is added [65]. From one year after surgery, questionnaires will be sent biennially until the end of follow-up (in case of only one surgery in the standard treatment arm) or until undergoing RRO (in the innovative arm). After RRO, data will be collected at six weeks and 3 and 12 months after surgery, comparable to follow-up after the first operation, and then biennial questionnaires will be sent until the end of follow-up, 15 years after the last (or only) surgery. Additionally, blood pressure, body mass index, waist-hip ratio and cardiovascular risk factors in fasting blood samples will be collected five years after each surgery. Follow-up by questionnaires will continue biennially until 15 years after the last surgery to detect occurrence of ovarian cancer. Since the wide possible range of age at inclusion, timing of surgeries and interval between surgeries, it is hard to specify and generalize the exact amount and timing of follow-up. A flowchart visualising the follow-up schedule can be found in Fig. 2.Fig. 2

Bottom Line: The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL).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.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics & Gynaecology, Radboud University Medical Center, PO Box 9101, , 6500 HB, Nijmegen, The Netherlands. Marline.Harmsen@radboudumc.nl.

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 ).

No MeSH data available.


Related in: MedlinePlus