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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Norman B Purvis, PhD
- Telefoonnummer: +44 (0)333 034 1690
- E-mail: npurvis@pierianbio.com
Studie Contact Back-up
- Naam: Robert Henry
- Telefoonnummer: +1 (615) 567-0200
- E-mail: rhenry@pierianbio.com
Studie Locaties
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Merseyside
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Liverpool, Merseyside, Verenigd Koninkrijk, L7 8YE
- Werving
- Liverpool University Hospital NHS Foundation Trust
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Contact:
- Ahsan Javed, MBBS, MD, MSc, PhD, FRCS
- Telefoonnummer: +44 (0)7701 013481
- E-mail: Ahsan.Javed@liverpoolft.nhs.uk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Colorectal Cancer Diagnosis
Beschrijving
Inclusion Criteria Group 1 Participants:
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≥18 years of age
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Diagnosis of CRC i. Surgical resection followed by adjuvant chemotherapy ii. Biopsy followed by neoadjuvant chemo/radiotherapy and surgical resection.
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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
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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)
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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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_CONTROL
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
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Group 1
Patients who have colorectal cancer and are referred for surgical resection with adjuvant chemotherapy after MDT discussion |
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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) |
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Group 3
Patients with locally advanced rectal cancer who have had a complete response to chemoradiotherapy (research objective) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Primary Objective
Tijdsspanne: Approximately 4 weeks post chemotherapy completion
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rosemary Lord, PhD FRCP, Clatterbridge Cancer Centre
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 202400129
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Plan to disseminate the findings and publish the findings, all data will be anonymised
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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