Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

January 30, 2024 updated by: National Cancer Centre, Singapore
Patients with cancers that are sensitive to radiotherapy treatment and/or patients who have experienced severe acute/ late side effects to radiotherapy will be recruited to the study. Blood and/or matched tumour-normal tissue pairs will be collected. Blood and/or tissue samples will be processed and studied for genetic and biochemical markers that have potential to be used for predicting sensitivity to radiation.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 169690
        • Recruiting
        • National Cancer Center Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from patients of the study team when they attend their regular clinic visits or when they are admitted to the hospital. These are patients from NCCS.

Description

Inclusion Criteria:

  • Patients with severe side effects from radiotherapy
  • Patients with a type of cancer that is associated with sensitivity to radiotherapy

Exclusion Criteria:

  • Age of patient must be between 21 (inclusive) and 99 (exclusive)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify genes or molecular pathways that are associated with radiation sensitivity in blood and tissue samples
Time Frame: Blood is taken at informed consent; tissue is from archived sample
Whole exome sequencing, single nucleotide polymorphism (SNP) assays
Blood is taken at informed consent; tissue is from archived sample
Change in immune profile of blood and tissue after radiation
Time Frame: Blood is taken at informed consent; tissue is from archived sample
Mass cytometry using CyTOF technology will be used to detect the immune cell population
Blood is taken at informed consent; tissue is from archived sample
To identify proteins that are associated with radiation sensitivity in tissue samples
Time Frame: Tissue is from archived sample
Immunohistochemistry will be used to detect protein expression
Tissue is from archived sample
To identify RNA expression pathways that are associated with radiation sensitivity in blood and tissue samples
Time Frame: Blood is taken at informed consent; tissue is from archived sample
RNA sequencing
Blood is taken at informed consent; tissue is from archived sample

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Ferring Pharmaceuticals
National Medical Research Council (NMRC), Singapore
Duke-NUS Graduate Medical School
ImmunoSCAPE
Decipher Biosciences

Investigators

  • Principal Investigator: Melvin Chua, MD, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2015

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (Actual)

April 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DISCLOSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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