Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

NCT04340024 | Recruiting

• 1 other identifier: DISCLOSE
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Cancer; Prostate Cancer; Other Cancer

Keywords

Radiotherapy; Biomarkers; Genomics; Immunomics; Precision medicine

Outcome Measures

Primary Outcomes (4)

• To identify genes or molecular pathways that are associated with radiation sensitivity in blood and tissue samples

  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

  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

  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

  RNA sequencing

  Blood is taken at informed consent; tissue is from archived sample

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Ferring Pharmaceuticals: collaborator
• ImmunoSCAPE: collaborator
• Decipher Biosciences: collaborator

Study Sites (1)

National Cancer Center Singapore

Singapore, 169690, Singapore

RECRUITING

Biospecimen

Retention: NONE RETAINED

20mL of blood will be collected up to 5 times over 5 years

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Melvin Chua, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melvin Chua, MD

CONTACT

melvin.chua.l.k@singhealth.com.sg

Enya Ong

CONTACT

+65 6436 8000; enya.ong.h.w@nccs.com.sg

Study Design

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

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 9, 2020
• Study Start: September 30, 2015
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)