Donation of Post Mortem Tumor Tissues

NCT03385980 | Completed

• 1 other identifier: 90/317/16
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

NSCLC Stage IV; CRC; CUP

Outcome Measures

Primary Outcomes (1)

• Intratumor heterogeneity

  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

  within 2-6 hours post-mortem

Secondary Outcomes (2)

• Potential impact on subsequent lines of therapy

  within 2-6 hours post-mortem

• Circulating free tumor DNA

  within 2-6 hours post-mortem

Study Arms (1)

Post-mortem patients

Post-mortem oncological patients (within 2-6 hrs from death, maximum time for tissue preservation).

Other: Proteomic analysis

Interventions

Proteomic analysis OTHER

Proteomic analysis of tissues collected from all sites of disease, guided by either imaging performed prior to the patient's death or post-mortem findings. Peripheral blood mononuclear cells (PBMC) will be collected with the purpose of identifying somatic changes occurring specifically in the tumor cells and not in normal DNA of the same patient.

Post-mortem patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), CUP (cancer of unknown origin syndrome)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Niguarda Hospital: lead
• University of Turin, Italy: collaborator
• Fondazione del Piemonte per l'Oncologia: collaborator

Study Sites (1)

ASST GOM Niguarda

Milan, 20162, Italy

Location

Related Publications (1)

• Siravegna 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Primary and metastatic tissues and peripheal blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Salvatore Siena, MD

  Niguarda Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 29, 2017
• Study Start: February 11, 2016
• Primary Completion: December 30, 2021
• Study Completion: April 30, 2022
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)