Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer

Brief summary (registry, in English)

This prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Tumour tissue and peripheral blood are profiled by whole-genome sequencing, single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing, spatial transcriptomics of formalin-fixed paraffin-embedded sections, multiplex immunofluorescence, and blood-based proteomic, cytokine and bulk T-cell receptor analyses. The study examines how immune and stromal states change during treatment and how they relate to major pathological response.

What you commit to

• Study type: Observational
• Planned participants: 100
• From 1 Jan 2025 to the primary completion date, 31 Dec 2028
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with locally advanced rectal cancer who will have treatment before surgery. Tumour tissue and blood are studied before and during treatment.

Age

18 to 75 years

Sex

All sexes can join.

Disease stage

Rectal adenocarcinoma confirmed under the microscope. Locally advanced disease (cT3-T4N0 or cT2-T4N+) with no distant metastasis. Lower edge of the tumour within 10 cm of the anal verge.

Earlier treatment

Scheduled to receive neoadjuvant therapy followed by surgery. Tumour tissue and blood must be available before and during neoadjuvant therapy.

Main reasons for not taking part

• Not enough tissue or poor nucleic acid quality for the planned tests
• Incomplete clinical records, so response cannot be assessed
• Another cancer within 5 years, except treated carcinoma in situ or basal cell carcinoma

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

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