NIPH Clinical Trials Search

ENSEMBLE-VISION

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Rectal cancer
Date of first enrollment	17/04/2026
Target sample size	48
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

The proportion of pathological complete response (pCR) and sustained clinical complete response (cCR), as well as the diagnostic accuracy, according to each set of response criteria.

Secondary Outcome

1 Interobserver agreement for endoscopic and MRI findings according to each set of response criteria 2) The proportion of pathological complete response (pCR) and sustained clinical complete response (cCR), as well as diagnostic accuracy, according to endoscopic findings 3) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, according to MRI findings 4) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, according to the level of confidence in endoscopic and MRI assessments 5) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, stratified by interobserver agreement in endoscopic and MRI evaluations 6) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, according to neoadjuvant chemotherapy regimens 7) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, according to pre-treatment endoscopic findings (macroscopic type, tumor size, location, and circumferential involvement) 8) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, according to pre-treatment MRI findings (depth of invasion, extramural venous invasion, mesorectal fascia involvement, lymph node metastasis, and tumor deposits) 9) The proportion of pCR and sustained cCR, as well as diagnostic accuracy, according to circulating tumor DNA (ctDNA) analysis results

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients who meet all of the following criteria: 1) Patients with rectal cancer who were enrolled in the ENSEMBLE-1 Trial or ENSEMBLE-2 Trial 2) Age: 18 years or older and 75 years or younger 3) Sex: not specified (both male and female eligible)
Exclude criteria	Patients who meet any of the following criteria: 1) Patients who discontinued or deviated from the protocol treatment in the ENSEMBLE-1 Trial or ENSEMBLE-2 Trial 2) Patients with missing endoscopic or MRI data before or after total neoadjuvant therapy (TNT) 3) Patients who declined participation in this study 4) Patients deemed inappropriate for inclusion by the principal investigator