Gene actionability according to the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT) in No Specific Molecular Profile (NSMP) endometrial cancer.
L Mastrantoni, F Camarda, C Parrillo...
https://pubmed.ncbi.nlm.nih.gov/40907210Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06020625
Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-08-31
20000
Participants Needed
1
Research Sites
452 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the use of comprehensive genomic profiling in cancer care to improve diagnosis and treatment. This study focuses on analyzing genetic information from tumor samples of various cancers, including lung, breast, ovary, pancreas, prostate, colorectum, melanoma, gastrointestinal stromal tumors, thyroid, endometrium, and cholangiocarcinoma. The goal is to identify gene alterations that may influence how patients respond to targeted therapies, supporting personalized medicine approaches. The study uses advanced sequencing technology to perform detailed genetic analysis on tumor samples already collected during diagnosis. Depending on the quality and quantity of the DNA or RNA extracted, patients' tumors undergo either comprehensive genome profiling covering at least 500 genes or targeted sequencing of panels with more than 50 genes. This approach allows for high-throughput genomic data generation at a reasonable cost and within a short timeframe. Participants will have their tumor samples processed to extract genetic material, which will be examined for mutations and other genomic changes. The study will monitor the comprehensive genomic profiles over a five-year period. This information is expected to help better understand cancer biology and support decisions around new molecularly targeted treatments. The trial is led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and involves no intervention beyond the genetic analyses on existing tissue samples.
CONDITIONS
Brief Title
Mutational Oncology in Clinical Practice
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosed with neoplasm of lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid, endometrium, or cholangiocarcinoma
- Breast cancer must be locally advanced or metastatic, hormone-responsive, HER2-negative, and progressing after endocrine therapy
- Lung cancer with metastatic disease
- Ovary cancer of any stage if nonmucinous, non-borderline epithelial carcinoma
- Pancreatic cancer with metastatic disease
- Prostate cancer with metastatic castration-resistant disease
- Colorectal cancer with metastatic disease
- Melanoma at stage IV or stage III undergoing surgery
- GIST profiling required for c-KIT in metastatic disease or surgery, and PDGFRα for inoperable or metastatic disease
- Availability of tumor tissue sample for genetic analysis
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 5 years
Participants undergo molecular characterization of tumor tissue through comprehensive genome profiling or targeted sequencing based on tumor sample quality and quantity.
1 visit for tumor tissue analysis
Long-term Monitoring
Duration - Up to 5 years
Participants are followed to assess outcomes related to the comprehensive genome profiling over several years.
Follow-up visits as needed over 5 years
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
Actively Recruiting
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Research Team
G
Giovanni Scambia
C
Camilla Nero
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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Published Research Related To This Trial
Network analysis of NRG1 variants of uncertain significance (VUSes) in advanced non-small-cell lung cancer and their prognostic role in EGFR-mutant patients treated with first-line osimertinib.
E Vita, A Scala, A Vitale...
https://pubmed.ncbi.nlm.nih.gov/40885102Impact of Comprehensive Genome Profiling on the Management of Advanced Non-Small Cell Lung Cancer: Preliminary Results From the Lung Cancer Cohort of the FPG500 Program.
Antonio Vitale, Luca Mastrantoni, Jacopo Russo...
https://pubmed.ncbi.nlm.nih.gov/39374480