Official Title
Donation of Post Mortem Tumor Tissues to Unravel Cancer Heterogeneity
Brief Title
Donation of Post Mortem Tumor Tissues
Protocol ID
NCT03385980
Lead Sponsor
Niguarda Hospital
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.
Detailed Description
Despite the recent technological advancement in genomic and proteomic, the molecular
understanding of clonal evolution in solid tumor patients is hampered by intra tumor
heterogeneity (ITH), while remaining essential to the effective treatment of patients.
Recent evidence suggests that branched evolutionary tumor growth may contribute to ITH
both within a primary tumor and between primary and metastatic tumors. To study the full
extent and consequences of ITH, and grasp clonal evolution, the investigators need to
have access not only to circulating biomarkers (circulating tumor DNA) but also,
simultaneously and separately, to the primary tumor and all its derived metastases.
However multiple biopsies in live patients are neither medically feasible, nor ethical
acceptable. A lesser known tissue collection method is through rapid tissue donation
(RTD), which is the procurement of 'fresh' tissue within 2 hrs following the death of a
patient. RTD-based research provides an effective way to investigate advance tumors
biology in a manner not possible by any other means. With an RTD approach, the full
extent and consequences of tumor heterogeneity can be evaluated by deep sequencing and
global analysis of genetic alterations at the protein level of simultaneous core biopsies
from several areas of the primary tumor and metastases and correlation with clinical
outcome. To investigators' knowledge, no such studies have been done in Italy and are
currently being pursued only in selected USA and UK cancer centers.
Study Period
-
Enrollment Count
20 participants
Eligibility Criteria
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).
Filters
NSCLC Stage IV
CRC
CUP
COMPLETED
CHILD
ADULT
OLDER_ADULT