Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

Prostate Cancer Clinical Trial

Official title:

Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340024
• Other study ID #: DISCLOSE
• Status: Recruiting
• Start date: September 30, 2015
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: Melvin Chua, MD
• Email: melvin.chua.l.k[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Other Cancer
• Prostate Cancer

Locations

Country	Name	City	State
Singapore	National Cancer Center Singapore	Singapore

Sponsors (6)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Decipher Biosciences, Duke-NUS Graduate Medical School, Ferring Pharmaceuticals, ImmunoSCAPE, National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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