ENSEMBLE-VISION

A Multi-center Observational Study Evaluating the Diagnostic Accuracy of Treatment Response Criteria After Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: Ancillary analysis of ENSEMBLE-1 and 2 study - ENSEMBLE-VISION

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1050260026

Enrollment

Registered

2026-04-17

Start date

2026-04-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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)

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactMasafumi Nishio

Yokohama City University Medical Center

mnishio@yokohama-cu.ac.jp+81-45-261-5656

Outcome results