Clinical trial · Observational
Donation of Post Mortem Tumor Tissues
Donation of Post Mortem Tumor Tissues to Unravel Cancer Heterogeneity
- 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)
DONUM is an observational prospective independent protocol for patients with advanced lung cancer, colorectal cancer or cancer of unknown primary, willing to donate their tumor tissue samples post mortem for biomedical research purposes. All patients who fulfill the inclusion criteria will be eligible for the study after giving their Informed consent. Informed Consent will be obtained in two steps. During the pre-information step patients will be acquainted with the existence of a post-mortem cancer tissue donation research program governed by the DONUM protocol. If the patients manifest interest to participate into the program (in writing) during the pre-information step, they will proceed to step 2 and undergo the final informed consent process.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
| CUP | Malignant Neoplasm of Unknown Primary | ALIAS | 0.90 |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proteomic analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Post-mortem patients
- description
- Post-mortem oncological patients (within 2-6 hrs from death, maximum time for tissue preservation).
- interventionNames
- Other: Proteomic analysis
Primary outcomes (1)
- measure
- Intratumor heterogeneity
- timeFrame
- within 2-6 hours post-mortem
- description
- Procure primary and metastatic tissue of selected solid tumor patients shortly after death in order to investigate ITH (intratumor heterogeneity), using integrated genomic and proteomic analysis
Secondary outcomes (2)
- measure
- Potential impact on subsequent lines of therapy
- timeFrame
- within 2-6 hours post-mortem
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Adult patients with confirmed metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), CUP (cancer of unknown origin syndrome) with life expectancy less than or equal to 3/4 months; * Age ≥18; * Signed informed consent from patient to enter the study and to undergo post-mortem tissue sampling. Exclusion Criteria: * Medical, or psychological conditions that would preclude informed consent; * History of high-risk infections (e.g. HIV-positive, hepatitis C, tuberculosis and Creutzfeldt-Jacob disease).
References
Publications (1)
- BACKGROUNDSiravegna G, Lazzari L, Crisafulli G, Sartore-Bianchi A, Mussolin B, Cassingena A, Martino C, Lanman RB, Nagy RJ, Fairclough S, Rospo G, Corti G, Bartolini A, Arcella P, Montone M, Lodi F, Lorenzato A, Vanzati A, Valtorta E, Cappello G, Bertotti A, Lonardi S, Zagonel V, Leone F, Russo M, Balsamo A, Truini M, Di Nicolantonio F, Amatu A, Bonazzina E, Ghezzi S, Regge D, Vanzulli A, Trusolino L, Siena S, Marsoni S, Bardelli A. Radiologic and Genomic Evolution of Individual Metastases during HER2 Blockade in Colorectal Cancer. Cancer Cell. 2018 Jul 9;34(1):148-162.e7. doi: 10.1016/j.ccell.2018.06.004. PMID 29990497