Tumor Molecular Profiling in Early Phase Clinical Trials

Recruiting

• Conditions: Advanced Solid Tumor; Lymphoma

• Registration Number: NCT04510766
• Lead Sponsor: Oncology Institute of Southern Switzerland

Brief Summary

Prospective, single centre, non-interventional exploratory research project that will be conducted on biological material and health-related personal data collected.

Detailed Description

Single center, two-parts pilot, prospective study to assess the role of molecular tumor profiling in supporting patient enrollment in early phase clinical trials.

Part A: patients with solid tumors or lymphomas (n=40) who are potential candidates for early phase clinical trials will be offered to have their more recent archival tumor tissue analyzed for the presence of somatic genomic alterations with the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 platform.

Part B: patients who have been enrolled in early phase clinical trials (estimated number: 16-18) will have their archival tumor tissue assessed with HTG EdgeSeq Oncology Biomarker Panel Assay for RNA-Seq to explore gene expression signatures and blood collected and stored to create a repository of samples (¨liquid biopsy¨) for future research with the aim to investigate the mutational profile of ctDNA at baseline and the acquisition of new mutations at the time of disease progression as a consequence of treatment exposure.

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2020-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accrual rate in early phase clinical trials	Two years	Number of patients with available molecular profile enrolled per year

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome	Two years	Response rate among patients with available molecular tumor profiling that have been enrolled in an early phase clinical trial
Rate of stored samples	Two years	Number of blood samples collected and stored for ctDNA analysis
Number of successful NGS-based DNA analysis performed on archival tissue	Two years	Type and frequency of mutations identified on archival tissue
Number of NGS-based RNA-seq samples analyzed	Two years	Analysis performed on archival tissue

Trial Locations

Locations (1)

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland