Pre-Clinical Validation of ChemoINTEL Unified Algorithm Chemotherapeutic Response Prediction in Patients With Colorectal Cancer

NCT07830407 | Recruiting

• 1 other identifier: 202400129
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-randomized, observational, pre-clinical validation study. Pierian Biosciences is utilizing ChemoINTEL assay measured in vitro cytotoxic drug induced apoptosis and cell death in isolated fresh human tumour cells from patients with colorectal cancer (CRC) to predict a patient's tumour's sensitivity to specific chemotherapy drugs using the ChemoINTEL unified algorithm. Eligible patients will be assigned to one of three groups depending on the stage of disease : Group 1: Patients who have colorectal cancer and are referred for adjuvant chemotherapy after MDT discussion. Group 2: Patients with stage II colorectal cancer with high risk features not referred for adjuvant chemotherapy (at risk of relapse) Group 3: Patients with locally advanced rectal cancer who have had a complete response to chemoradiotherapy (research objective). At least one solid tumour specimen and adjacent normal tissue will be sent to Pierian Biosciences Laboratory in Liverpool, UK along with an optional 10-20ml blood sample and The Pierian Biosciences laboratory staff will conduct the ChemoINTEL and ImmunoINTEL assays blinded to all specimen and clinical information except the tumor type (e.g. Colon Cancer or Rectal Cancer), Specimen ID, and specimen collection date and time. Results of the assay will NOT be shared with clinical sites. Samples from group 3 will be provided if patients undergo surgical resection.

Conditions

Colorectal Cancer

Keywords

ChemoINTEL; Colorectal

Outcome Measures

Primary Outcomes (1)

• Primary Objective

  To evaluate Group 1 ChemoINTEL Assay Unified Algorithm's prediction accuracy of clinical response to chemotherapy in patients with minimal residual colorectal cancer disease detectable by ctDNA post-surgery (prior to Cycle 1 chemotherapy) using patient response assessed by ctDNA measured 4 weeks post chemotherapy completion

  Approximately 4 weeks post chemotherapy completion

Study Arms (3)

Group 1

Patients who have colorectal cancer and are referred for surgical resection with adjuvant chemotherapy after MDT discussion

Group 2

Patients with stage II colorectal cancer with high risk features referred for surgical resection but not referred for adjuvant chemotherapy (at risk of relapse)

Group 3

Patients with locally advanced rectal cancer who have had a complete response to chemoradiotherapy (research objective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Colorectal Cancer Diagnosis

You may qualify if:

• ≥18 years of age
• Diagnosis of CRC i. Surgical resection followed by adjuvant chemotherapy ii. Biopsy followed by neoadjuvant chemo/radiotherapy and surgical resection.
• Patients planned to receive at least 6 cycles of standard of care chemotherapy for CRC with single agent or combination of drugs listed in Table 3 following biopsy OR surgical resection
• One solid tumor specimen is required; a total of two specimens are preferred and requested when available. Specimens will include:
• i. Primary solid tumor specimen (≥400 mg) ii. Adjacent normal tissue (\>400mg)
• Patient signed Informed Consent Form

You may not qualify if:

• Patient has not signed an ICF to participate in a clinical investigation
• Patient has a cancer other than advanced stage CRC
• Patient is NOT expected to receive SOC chemotherapy, single agents or combination treatment, as listed in Table 3
• Patients who do not have at sufficient viable cells recovered from fresh tumor dissociation available for the ChemoINTEL assay analysis of Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Capecitabine

Sponsors & Collaborators

• Pierian Biosciences: lead

Study Sites (1)

Liverpool University Hospital NHS Foundation Trust

Liverpool, Merseyside, L7 8YE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Solid Tumor Normal Adjacent Tissue Blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rosemary Lord, PhD FRCP

  Clatterbridge Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norman B Purvis, PhD

CONTACT

+44 (0)333 034 1690; npurvis@pierianbio.com

Robert Henry

CONTACT

+1 (615) 567-0200; rhenry@pierianbio.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)