Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07395505
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged ≥20 years.
* Histologically confirmed rectal adenocarcinoma or anal adenocarcinoma.
* Tumor invasion of sacrum (requiring sacrectomy, S2-S4) or anterior structures (e.g., prostate), or lateral structures(SLAM, vessels, nerve) where resection of the invaded organ is necessary to achieve R0 resection, as determined by MDT.
* Surgical candidacy confirmed by multidisciplinary review (colorectal surgery, urology, orthopedics, oncology, radiology, pathology).
* Preoperative imaging (MRI, PET/CT) confirming resectable disease without distant metastasis.
* Signed informed consent obtained.
Exclusion Criteria:
* Unresectable disease or widespread distant metastasis.
* Severe comorbidities rendering major surgery or anesthesia unsafe.
* Patients unable to complete postoperative follow-up or unwilling to participate in PROMs assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07395505
Study Brief:
Protocol Section:
NCT07395505