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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Norman B Purvis, PhD
- 電話番号：+44 (0)333 034 1690
- メール：npurvis@pierianbio.com
研究連絡先のバックアップ
- 名前：Robert Henry
- 電話番号：+1 (615) 567-0200
- メール：rhenry@pierianbio.com
研究場所
-
-
Merseyside
-
Liverpool、Merseyside、イギリス、L7 8YE
- 募集
- Liverpool University Hospital NHS Foundation Trust
-
コンタクト：
- Ahsan Javed, MBBS, MD, MSc, PhD, FRCS
- 電話番号：+44 (0)7701 013481
- メール：Ahsan.Javed@liverpoolft.nhs.uk
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Colorectal Cancer Diagnosis
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Objective
時間枠：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 |
Approximately 4 weeks post chemotherapy completion
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Rosemary Lord, PhD FRCP、Clatterbridge Cancer Centre
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 202400129
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Plan to disseminate the findings and publish the findings, all data will be anonymised
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。