Clinical trial · Observational
Prospective Tissue Collection Research Protocol
Prospective Collection of Donor Tissue and Whole Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)
NCT03517917CI-TRIAL-00090106completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumour tissue collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Arm 1
- description
- Tumour tissue, blood and leukapheresis collection to enable a manufacturing process for immunotherapies to be developed.
- interventionNames
- Other: Tumour tissue collection
Primary outcomes (1)
- measure
- Obtaining samples for research
- timeFrame
- 5 years
- description
- This protocol does not have an analysis primary outcome measure. It will be conducted in accordance with the principles of Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥ 18 years * Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation. * Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease. * Patient is scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy, has a superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study. * Haemoglobin(Hb) ≥ 10g/dL without transfusion support for at least 3 weeks (for patients donating whole blood). White cell count ≥ 3 x 10\^9/L (for patients donating whole blood). * For selected solid tumours and leukapheresis procedure additional inclusion criteria apply. Exclusion Criteria: * Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue. * Inadequate peripheral venous access precluding collection of blood. * Pregnant or breastfeeding women. * Known/laboratory confirmed diagnosis of an active infectious disease to include Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis. * Patients who are currently participating in a clinical trial involving an unlicensed medical product. * Patients who have received any cytotoxic therapy (including investigational products) within three weeks prior to tissue procurement. * Patients receiving immunosuppressive treatments or who require regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent). * Any medical reason why, in the opinion of the investigator, the patient should not participate in this study. * For selected solid tumours and leukapheresis procedure additional exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.