Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors

Advanced Cancer Clinical Trial

Official title:

Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04110223
• Other study ID #: GBRT-043
• Status: Recruiting
• Start date: October 8, 2018
• Est. completion date: October 8, 2021

Study information

• Verified date: September 2019
• Source: Shandong Cancer Hospital and Institute
• Contact: Shuanghu Yuan Ph.D
• Phone: +8613853106916
• Email: yuanshuanghu[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Despite the common application of radiotherapy in cancer treatment, the prediction of radiosensitivity and treatment response has not yet entered the era of precision medicine. Therefore, development of genome-based methods for predicting radiosensitivity and treatment response is a central goal of radiation oncology. In the previous study, the investigators have identified a set of novel potential biomarkers associated with radiosensitivity and recurrence，through correlating patients' genomic profiles with toxicity, disease progression and overall survival after RT.

Description:

Researchers have long recognized that individual differences in sensitivity to radiation are caused by genetic variations and implicated multiple key pathways that might explain radiation toxicity. Normal tissue toxicity is a complex trait that involves the combined effect of a multitude of genes and pathways, and also dynamic interactions with the evolving cancer genome. The effect size of any individual factor is likely small. As a consequence, candidate gene approach and genome-wide association studies rarely lead to the identification of genetic determinants of radiation toxicity. Targeted next-generation sequencing (NGS), on the other hand, has become increasingly routine in the clinic and would allow simultaneous assessment of multiple genetic alterations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 8, 2021
• Est. primary completion date: October 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with locally advanced solid tumors (lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma cancer and liver cancer) identified by cytology and pathology;

2. Patients need conventional fractionation and adequate radiotherapy;

3. Age = 18 years old, male and female;

4. Expected survival time = 12 weeks;

5. PS score 0-2 within 2 weeks before admission to the group;

6. There are tumor tissue samples and blood samples can be used for NGS inspection;

7. Patients volunteered to join this study, sign informed consent, provide all diagnosis and treatment data after cancer diagnosis before entering the group, good compliance, cooperate with follow-up.

Exclusion Criteria:

1. The patient's previous radiation therapy leads to overlapping potential fields;

2. Stage IV patients and stage I patients to be treated with SBRT

3. The patient cannot receive regular imaging examinations;

4. Any serious or uncontrolled signs of systemic disease that the investigator believes may significantly affect the patient's risk/benefit balance, including hepatitis B, hepatitis C, and human immunodeficiency virus;

5. The researcher believes that it is not suitable for the group.

Related Conditions & MeSH terms

• Advanced Cancer
• Radiation Toxicity
• Radiosensitivity

Intervention

Genetic:
• next generation sequence
targeted NGS of patients' pretreatment tumor biopsy samples using a 474-gene panel, which covers cancer- and radio-sensitivity-related mutations and SNPs.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital and Institute	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TTP	Time to progression	2 years
Primary	OS	Time to death	2 years