Using genetic profiling to improve cancer treatment
Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
This study is testing if using genetic information can help doctors choose better treatments for cancer patients based on their specific tumor characteristics.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT06020625 on ClinicalTrials.gov |
What this trial studies
This study focuses on the integration of molecular characterization into clinical practice to enhance the diagnosis and treatment of various cancers. By utilizing next-generation sequencing (NGS), the study aims to analyze a large number of samples simultaneously, generating extensive genomic data that can identify oncogenic drivers and gene alterations. These insights are crucial for predicting patient responses to new molecularly targeted therapies, particularly for patients with specific types of neoplasms. The research is conducted at Policlinico A. Gemelli, which has been recognized for its commitment to personalized medicine and innovative biotechnology.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic cancers such as lung, breast, ovarian, pancreatic, prostate, colorectal, melanoma, GIST, thyroid, endometrial, and cholangiocarcinoma.
Not a fit: Patients with early-stage cancers or those not meeting the specific cancer types outlined in the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized cancer treatments for patients based on their genetic profiles.
How similar studies have performed: Other studies utilizing genetic profiling and NGS have shown promising results in improving treatment outcomes for cancer patients, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
\- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma: 1. BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy. 2. LUNG Metastatic disease. 3. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma. 4. PANCREAS Metastatic disease. 5. PROSTATE Metastatic castration-resistant disease. 6. COLORECTUM Metastatic disease. 7. MELANOMA Stage IV or stage III undergoing surgery. 8. GIST Profiling of c-KIT in case of metastatic disease or for patients undergoing surgery and of PDGFRα for all patients with inoperable or metastatic disease. 9. THYROID 10. ENDOMETRIUM 11. CHOLANGIOCARCINOMA
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Scambia
- Email: giovanni.scambia@policlinicogemelli.it
- Phone: 0630158668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.