Trial record 1 of 1 for:
NCT02321228
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers (TUBA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02321228 |
|
Recruitment Status :
Active, not recruiting
First Posted : December 22, 2014
Last Update Posted : May 18, 2022
|
Sponsor:
University Medical Center Nijmegen
Information provided by (Responsible Party):
Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| BRCA1 Gene Mutation BRCA2 Gene Mutation Ovarian Cancer | Procedure: Salpingectomy with delayed oophorectomy Procedure: Risk-reducing salpingo-oophorectomy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 510 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 Start Date : | January 2015 |
| Estimated Primary Completion Date : | January 2025 |
| Estimated Study Completion Date : | January 2035 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Genes and Gene Therapy
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Salpingectomy with delayed oophorectomy
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).
|
Procedure: Salpingectomy with delayed oophorectomy
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.
Other Name: Tubectomy with delayed oophorectomy |
|
Active Comparator: Risk-reducing salpingo-oophorectomy
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).
|
Procedure: Risk-reducing salpingo-oophorectomy
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.
Other Name: Bilateral prophylactic salpingo-oophorectomy |
Primary Outcome Measures :
- Menopause-related quality of life [ Time Frame: Up to 5 years after last surgery ]Measured by the Greene Climacteric Scale
Secondary Outcome Measures :
- General quality of life [ Time Frame: Up to 15 years after last surgery ]measured by several questionnaires
- Quality of life related items [ Time Frame: Up to 15 years after last surgery ]i.e. sexual functioning, cancer worry, satisfaction with decision
- Surgery-related complications [ Time Frame: 6 weeks after each surgery ]Surgery-related complications
- Histopathologic findings of removed fallopian tubes and ovaries [ Time Frame: 6 weeks after each surgery ]- Histopathologic findings of removed fallopian tubes and ovaries
- Cardiovascular risk factors [ Time Frame: Up to 5 years after last surgery ]Limited physical examination: blood pressure, BMI, waist-hip ratio Blood sample Questionnaires on cardiovascular risk factors and diseases
- Incidence of cardiovascular diseases [ Time Frame: Up to 15 years after last surgery ]i.e. waist-hip circumference, Fasting blood sample
- Incidence of ovarian cancer [ Time Frame: Up to 15 years after last surgery ]Incidence of ovarian cancer (cancer of tubes, ovaries and/or peritoneal cancer)
- Incidence of breast cancer [ Time Frame: Up to 15 years after last surgery ]Incidence of breast cancer
- Cost-effectiveness of innovative preventive strategy [ Time Frame: 10 years after last surgery ]Costs per quality adjusted life year (QALY)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 25 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321228
Locations
| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Limburg, Netherlands, 6229 HX | |
| Catharina Hospital | |
| Eindhoven, Noord-Brabant, Netherlands, 5623 EJ | |
| Elisabeth-TweeSteden Hospital | |
| Tilburg, Noord-Brabant, Netherlands, 5042 AD | |
| Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Noord-Holland, Netherlands, 1066 CX | |
| Leiden University Medical Center | |
| Leiden, Zuid-Holland, Netherlands, 2333 ZA | |
| Erasmus Medical Center | |
| Rotterdam, Zuid-Holland, Netherlands, 3015 CE | |
| Academic Medical Center | |
| Amsterdam, Netherlands | |
| VU University Medical center | |
| Amsterdam, Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9713 GZ | |
| Medical Center | |
| Leeuwarden, Netherlands | |
| Radboudumc | |
| Nijmegen, Netherlands | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Maxima Medical Center | |
| Veldhoven, Netherlands | |
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
| Principal Investigator: | Joanne A de Hullu, MD, PhD | University Medical Center Nijmegen | |
| Principal Investigator: | Rosella PM Hermens, PhD | Scientific Institute for Quality of Healtcare, UMCNijmegen | |
| Principal Investigator: | Nicoline Hoogerbrugge, MD, PhD | University Medical Center Nijmegen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joanne A. de Hullu, MD, PhD, MD, PhD, gynecologic oncologist, principal clinician, University Medical Center Nijmegen |
| ClinicalTrials.gov Identifier: | NCT02321228 |
| Other Study ID Numbers: |
NL50048.091.14 |
| First Posted: | December 22, 2014 Key Record Dates |
| Last Update Posted: | May 18, 2022 |
| Last Verified: | May 2022 |
Keywords provided by Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen:
|
Salpingectomy Delayed oophorectomy Salpingo-oophorectomy |
Quality of life Ovarian cancer BRCA |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders |