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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04110223
Enrollment
600
Registered
2019-10-01
Start date
2018-10-08
Completion date
2021-10-08
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Radiation Toxicity, Radiosensitivity

Keywords

radiotherapy, radiosensitivity, radiation toxity, NGS

Brief 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.

Detailed 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.

Interventions

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

Sponsors

Shandong Cancer Hospital and Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
TTP2 yearsTime to progression
OS2 yearsTime to death

Countries

China

Contacts

Primary ContactShuanghu Yuan Ph.D
yuanshuanghu@sina.com+8613853106916
Backup ContactYong M Shao, Ph.D
yang.shao@geneseeq.com025-58461736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026