Tumor Molecular Profiling in Early Phase Clinical Trials

NCT04510766 | Recruiting

• 1 other identifier: IOSI-USNF-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Accrual rate in early phase clinical trials

  Number of patients with available molecular profile enrolled per year

  Two years

Secondary Outcomes (4)

• Clinical Outcome

  Two years

• Number of successful NGS-based DNA analysis performed on archival tissue

  Two years

• Number of NGS-based RNA-seq samples analyzed

  Two years

• Rate of stored samples

  Two years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Male or female patients age at least 18 years.
• Patients with histological diagnosis of advanced solid tumor or lymphoma who are potential candidates for early phase clinical trials.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Live expectancy of at least 6 months.
• Availability of FFPE archival tumor tissue from previous surgery or diagnostic biopsy adequate for molecular analysis.
• Ability to understand the patient information and study consent. Signed and dated written informed consent must be available before performing any study-related procedure.
• Willing and able to comply with study procedures

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oncology Institute of Southern Switzerland: lead
• Ente Ospedaliero Cantonale, Bellinzona: collaborator
• Istituto Cantonale di Patologia: collaborator

Study Sites (1)

Oncology Institute of Southern Switzerland

Bellinzona, 6500, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumor tissue and liquid biopsy

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ilaria Colombo, MD

  Oncology Institute of Southern Switzerlan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Colombo, MD

CONTACT

+41 (0)91 811 8194; ilaria.colombo@eoc.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CH (1)