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

NCT ID: NCT04110223

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-08

Study Completion Date

2021-10-08

Brief Summary

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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

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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.

Conditions

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Radiation Toxicity Advanced Cancer Radiosensitivity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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non-smell cell lung cancer (NSCLC)

Advanced NSCLC patients receiving radiotherapy or chemo-radiotherapy

next generation sequence

Intervention Type GENETIC

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

Rectal cancer

Rectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy

next generation sequence

Intervention Type GENETIC

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

Smell cell lung cancer (SCLC)

SCLC patients receiving radiotherapy or chemo-radiotherapy

next generation sequence

Intervention Type GENETIC

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

Esophageal cancer

Esophageal cancer patients receiving radiotherapy or chemo-radiotherapy

next generation sequence

Intervention Type GENETIC

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

Cervical cancer

Cervical cancer patients receiving radiotherapy or chemo-radiotherapy

next generation sequence

Intervention Type GENETIC

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

Liver cancer

Liver cancer atients receiving radiotherapy or chemo-radiotherapy

next generation sequence

Intervention Type GENETIC

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

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Cancer Hospital and Institute

OTHER

Sponsor Role lead

Responsible Party

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Jinming Yu

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinming Yu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

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Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuanghu Yuan Ph.D

Role: CONTACT

+8613853106916

Yong M Shao, Ph.D

Role: CONTACT

025-58461736

Facility Contacts

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Jinming Yu

Role: primary

8653167626891

Other Identifiers

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GBRT-043

Identifier Type: -

Identifier Source: org_study_id

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