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NCT Number: NCT07830407

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool University Hospital NHS Foundation Trust

Liverpool, Merseyside, L7 8YE, United Kingdom

Location status: Recruiting

Location contact

Ahsan Javed, MBBS, MD, MSc, PhD, FRCS

CONTACT

[email protected]

+44 (0)7701 013481

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Group 1 Participants:

≥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

Exclusion criteria

Group 1 Participants:

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

Treatment and study plan

Primary outcomes

Primary Objective

Time frame: Approximately 4 weeks post chemotherapy completion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Norman B Purvis, PhD

CONTACT

[email protected]

+44 (0)333 034 1690

Robert Henry

CONTACT

[email protected]

+1 (615) 567-0200

Sponsors and collaborators

Lead sponsor

Pierian Biosciences

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2030
First posted: Sep 21, 2026
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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