Prospective Collection of Tumor Biopsy and Plasma Samples From Cancer Patients Treated With Molecular Targeted Therapies or Immunotherapy

NCT03835520 | Active Not Recruiting

• 3 other identifiers: UCL-ONCO 2018-022018/11JUI/248B403201836842
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect blood samples, as well as tumor tissue for genetic analysis. The collection of samples will allow the creation of a plasma bank. Targeted individuals are cancer patients of all types, treated with immunotherapy or targeted therapy. Immunotherapy or targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions. With the aim to identify predictive markers of response to treatment or possible resistance mechanism, the plasma samples and the tumor samples will be used for genetic analysis, for example but not limited to, whole exome sequencing. This may lead to the discovery of some germinal mutations implicated in other diseases than cancer.

Conditions

Cancer

Keywords

Immunotherapy; Molecular Targeted Therapies; Tumor Biopsy; Plasma Samples

Outcome Measures

Primary Outcomes (1)

• efficacy of treatment against Cancer

  Efficacy will be determined in terms of overall responses according to standard practice by the local investigator. Disease and response assessments are defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Secondary Outcomes (3)

• Overall survival (OS)

  From date of randomization until the date of first documented progression assessed up to 120 months

• Progression free survival

  From date of randomization until the date of first documented progression , assessed up to 120 months

• Objective tumor response

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months

Study Arms (2)

MOLECULAR TARGETED THERAPIES

EXPERIMENTAL

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

Drug: Molecular Target

IMMUNOTHERAPY

EXPERIMENTAL

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

Drug: Immunotherapeutic Agent

Interventions

Immunotherapeutic Agent DRUG

Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.

IMMUNOTHERAPY

Molecular Target DRUG

Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.

MOLECULAR TARGETED THERAPIES

Eligibility Criteria

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

You may qualify if:

• Patients with cancer treated with one of the following regimens: Molecular targeted agents or Immunotherapy
• Paraffin-embedded tumor tissue available for immunohistochemistry and/or DNA extraction.
• Patient able to give written informed consent.

You may not qualify if:

• Patients with cancer treated with other regimen

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Adjuvants, Immunologic; Rv1579c phage protein, Mycobacterium tuberculosis

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Masking and allocation tbc
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will include patients with any type of cancer treated with one of the following regimens after signing of the patient's informed consent: * I: Molecular targeted agent * II: Immunotherapy

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: February 8, 2019
• Study Start: July 11, 2018
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)