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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Norman B Purvis, PhD
- Telefonnummer: +44 (0)333 034 1690
- E-Mail: npurvis@pierianbio.com
Studieren Sie die Kontaktsicherung
- Name: Robert Henry
- Telefonnummer: +1 (615) 567-0200
- E-Mail: rhenry@pierianbio.com
Studienorte
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Merseyside
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Liverpool, Merseyside, Vereinigtes Königreich, L7 8YE
- Rekrutierung
- Liverpool University Hospital NHS Foundation Trust
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Kontakt:
- Ahsan Javed, MBBS, MD, MSc, PhD, FRCS
- Telefonnummer: +44 (0)7701 013481
- E-Mail: Ahsan.Javed@liverpoolft.nhs.uk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Colorectal Cancer Diagnosis
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: CASE_CONTROL
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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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) |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Primary Objective
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Rosemary Lord, PhD FRCP, Clatterbridge Cancer Centre
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 202400129
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Plan to disseminate the findings and publish the findings, all data will be anonymised
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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