Tumor Molecular Profiling in Early Phase Clinical Trials

Lymphoma Clinical Trial

Official title:

Molecular Characterization of Solid Tumors and Lymphomas to Optimize the Drug Development Process and Patients Enrollment in Early Phase Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510766
• Other study ID #: IOSI-USNF-001
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Oncology Institute of Southern Switzerland
• Contact: Ilaria Colombo, MD
• Phone: +41 (0)91 811 8194
• Email: ilaria.colombo[@]eoc.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Lymphoma

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland	Bellinzona

Sponsors (3)

Lead Sponsor	Collaborator
Oncology Institute of Southern Switzerland	Ente Ospedaliero Cantonale, Bellinzona, Istituto Cantonale di Patologia

Country where clinical trial is conducted

Switzerland, 

Outcome

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