Tumor Molecular Profiling 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

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

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Advanced Solid Tumor

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ilaria Colombo, MD; Phone Number: +41 (0)91 811 8194; Email: ilaria.colombo@eoc.ch

Study Locations

• Switzerland
  • Bellinzona, Switzerland, 6500
    • Recruiting
    • Oncology Institute of Southern Switzerland
    • Contact: Ilaria Colombo, MD; Phone Number: +41 (0)91 811 8194; Email: ilaria.colombo@eoc.ch
    • Principal Investigator: Anastasios Stathis, PD MD
    • Principal Investigator: Milo Frattini, PhD
    • Principal Investigator: Francesco Bertoni, Prof. MD
    • Principal Investigator: Davide Rossi, Prof. MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Part A; Upon confirmation of the suitability for NGS analysis of the selected tumor sample, tumor DNA will be extracted and molecular profile will be performed using the pan-cancer NGS Ion TorrentTM OncomineTM Comprehensive Assay v3 according to manufacturer's instructions
Part B; FFPE tumor archival tissue will be used to perform RNA-Seq with NGS HTG EdgeSeq Oncology Biomarker Panel Assay using the HTG machine following the manufacture's protocol. Blood samples for "liquid biopsy" will be collected at two time points: 1) Any time after enrollment in an early clinical trial and before starting the investigational agent (1 x 10 ml blood sample in EDTA tube as source of normal DNA for comparative analysis; 2 x 10 ml blood samples in cell-free DNA BCT Tubes for ctDNA collection; 2) At the time of radiological or clinical tumor progression (2 x 10 ml blood samples in cell-free DNA BCT Tubes for ctDNA collection). Blood samples will be collected and stored to create a biobank of "liquid biopsy" for future analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accrual rate in early phase clinical trials	Number of patients with available molecular profile enrolled per year	Two years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oncology Institute of Southern Switzerland
• Collaborators: Ente Ospedaliero Cantonale, Bellinzona; Istituto Cantonale di Patologia
• Investigators: Principal Investigator: Ilaria Colombo, MD, Oncology Institute of Southern Switzerlan

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: IOSI-USNF-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No