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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Norman B Purvis, PhD
- 전화번호: +44 (0)333 034 1690
- 이메일: npurvis@pierianbio.com
연구 연락처 백업
- 이름: Robert Henry
- 전화번호: +1 (615) 567-0200
- 이메일: rhenry@pierianbio.com
연구 장소
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Merseyside
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Liverpool, Merseyside, 영국, L7 8YE
- 모병
- Liverpool University Hospital NHS Foundation Trust
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연락하다:
- Ahsan Javed, MBBS, MD, MSc, PhD, FRCS
- 전화번호: +44 (0)7701 013481
- 이메일: Ahsan.Javed@liverpoolft.nhs.uk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Colorectal Cancer Diagnosis
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
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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) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Objective
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Rosemary Lord, PhD FRCP, Clatterbridge Cancer Centre
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 202400129
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Plan to disseminate the findings and publish the findings, all data will be anonymised
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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