Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
This prospective watch-and-measure (no experimental treatment required) 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.
Official registry: https://clinicaltrials.gov/study/NCT07920770 · Fujian Medical University Union Hospital · enrollment listed as 100
What this phase means
This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.
They plan to enroll about 100 people at Fuzhou. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
A Prospective Observational Study of Tumour Microenvironment Remodelling During Neoadjuvant Therapy in Locally Advanced Rectal Cancer Using Single-Cell and Spatial Multi-omics
Primary outcome (registry wording): Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy
Who it is for (from inclusion criteria)
- Eastern Cooperative Oncology Group performance status 0-1
- Histologically confirmed rectal adenocarcinoma
- Locally advanced disease staged as cT3-T4N0 or cT2-T4N+ without distant metastasis (AJCC 8th edition)
- Lower border of the tumour within 10 cm of the anal verge
- Scheduled to receive neoadjuvant therapy followed by surgery, with tumour tissue and peripheral blood available before and during neoadjuvant therapy
Who the registry excludes
- Insufficient tissue or nucleic acid quality for the planned profiling assays
- Incomplete clinical records precluding assessment of pathological or clinical response
- A history of other malignancy within 5 years other than adequately treated carcinoma in situ or basal cell carcinoma
Public study contact (from the registry)
Wan-cai Que
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (recruiting)
FAQ about this NCT record
Is NCT07920770 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07920770?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07920770?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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