Analyzing tumor samples to help enroll patients in early phase clinical trials
Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials
This study is trying to see if analyzing tumor samples can help doctors find the right patients for early clinical trials for advanced cancers and lymphomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oncology Institute of Southern Switzerland Academic / other |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT04510766 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of molecular tumor profiling in facilitating patient enrollment in early phase clinical trials for advanced solid tumors and lymphomas. It consists of two parts: the first part involves analyzing archival tumor tissue from potential candidates to identify genomic alterations, while the second part assesses tumor tissue from patients already enrolled in trials to investigate gene expression and collect blood samples for future research. The study will utilize advanced genomic sequencing technologies to gather comprehensive data on tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of advanced solid tumors or lymphomas who are potential candidates for early phase clinical trials.
Not a fit: Patients with other active malignancies or those with conditions that disqualify them from early phase clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the precision of patient matching for early phase clinical trials, potentially leading to better treatment outcomes.
How similar studies have performed: Other studies utilizing molecular profiling for patient enrollment in clinical trials have shown promising results, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients age at least 18 years. 2. Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 4. Live expectancy of at least 6 months. 5. Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis. 6. Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure. 7. Willing and able to comply with study procedures Exclusion Criteria: 1. Presence of any clinical (e.g. concomitant disease, clinically significant symptoms, or non-clinical (psychological or social) conditions that would not make the patient eligible for enrolment in an early phase clinical trial. 2. Any other active malignancy (other than the one for which the subject is being assessed for trial option) that is progressing or requiring active treatment with the exception of basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of any site.
Where this trial is running
Bellinzona
- Oncology Institute of Southern Switzerland — Bellinzona, Switzerland (Recruiting)
Study contacts
- Principal investigator: Ilaria Colombo, MD — Oncology Institute of Southern Switzerlan
- Study coordinator: Ilaria Colombo, MD
- Email: ilaria.colombo@eoc.ch
- Phone: +41 (0)91 811 8194
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.