Role Of Ovarian Metastases In Colorectal Cancer (ROMIC): a Dutch study protocol to evaluate the effect of prophylactic salpingo-oophorectomy in postmenopausal wome
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- NL-OMON28366
- Lead Sponsor
- Rudi Roumen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1991
Inclusion Criteria
1. Female gender
2. Age =60 years at the time of CRC diagnosis
3. Intended curative resection of colon or rectal cancer, with no evidence of incurable distant metastases
4. informed consent or consent by opt-in form
Exclusion Criteria
1. No signed informed consent and no consent by opt-in form
2. surgery with palliative intent
3. Known distant metastases preoperatively, or evidence of distant or intraperitoneal metastases during operation, except when curative metastasectomy is considered possible
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main aim of this study is to determine whether prophylactic bilateral salpingo-oophorectomy conducted in postmenopausal patients aged =60 years during surgery for primary CRC reduces the incidence of ovarian malignancies (metastatic or primary) during a three-year follow-up period. Moreover, this study will provide the data necessary to calculate the number needed to treat (NNT) in order to prevent one case of ovarian cancer (metastatic or primary).
- Secondary Outcome Measures
Name Time Method