Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
NCT07920770, Recruiting, Fujian Medical University Union Hospital
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer | ClinicalTrials.gov |
| NCT number | NCT07920770 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fujian Medical University Union Hospital | ClinicalTrials.gov |
| Conditions | Rectal Neoplasms | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy | Baseline (before treatment) and week 4 after treatment initiation | Cell-type composition and transcriptional states of T, natural killer (NK), B and myeloid populations and of stromal subsets before treatment and during neoadjuvant therapy, determined by single-cell RNA sequencing. | ClinicalTrials.gov |
| Primary | Major pathological response (mPR) and its association with immune microenvironment features | Through study completion, an average of 4 years | Proportion of patients achieving major pathological response, defined as 10% or less residual viable tumour at resection, and the association of pre-treatment and on-treatment immune microenvironment features with mPR. | ClinicalTrials.gov |
| Secondary | Transcriptional states of immune populations before and during treatment | Baseline (before treatment) and week 4 after treatment initiation | Exhaustion, activation and memory programmes of T and NK cells and B-cell states, determined by single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing. | ClinicalTrials.gov |
| Secondary | Spatial organisation of tumour and immune compartments before and during treatment | Baseline (before treatment) and week 4 after treatment initiation | Spatial distribution of tumour, immune and stromal compartments determined by spatial transcriptomics of formalin-fixed paraffin-embedded sections and multiplex immunofluorescence, compared with specimens from treatment-naive patients undergoing primary surgery and from end-of-treatment biopsies as controls. | ClinicalTrials.gov |
| Secondary | Comparison of microenvironment remodelling between neoadjuvant treatment sequences | Through study completion, an average of 4 years | Between-group comparison of the change in tumour microenvironment composition between baseline and week 4, expressed as the percentage of cluster of differentiation 8 (CD8)-positive T cells, NK cells, B cells and plasma cells among all cells measured by single-cell RNA sequencing, in patients receiving radiotherapy before versus after chemo-immunotherapy. | ClinicalTrials.gov |
| Secondary | Somatic genomic alterations associated with response to neoadjuvant therapy | Baseline (before treatment) and week 4 after treatment initiation | Somatic mutations, copy-number alterations and mutational signatures determined by whole-genome sequencing of tumour tissue before and during neoadjuvant therapy. | ClinicalTrials.gov |
| Secondary | Clonal diversity of the peripheral blood T-cell receptor repertoire | Baseline (before treatment) and week 4 after treatment initiation | Diversity and distribution of T-cell receptor clonotypes in peripheral blood mononuclear cells, expressed as the Shannon diversity index and the proportion of expanded clonotypes, measured by bulk T-cell receptor repertoire sequencing. | ClinicalTrials.gov |
| Secondary | Correlation of tumour microbial composition with major pathological response | Baseline (before treatment) and week 4 after treatment initiation | Correlation between the relative abundance of tumour-associated bacterial taxa, expressed as the percentage of sequencing reads assigned to each taxon measured by small-subunit ribosomal RNA gene sequencing or shotgun metagenomic sequencing of tumour tissue, and major pathological response, expressed as the percentage of patients with 10% or less residual viable tumour at resection (exploratory). | ClinicalTrials.gov |
| Secondary | Plasma protein and cytokine concentrations before and during neoadjuvant therapy | Baseline (before treatment) and week 4 after treatment initiation | Concentrations of plasma or serum proteins and cytokines, expressed in pg/mL, measured by multiplex proteomic and cytokine assays. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)