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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110223
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jinming Yu, Shandong Cancer Hospital and Institute

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.

Condition or disease Intervention/treatment
Radiation Toxicity Advanced Cancer Radiosensitivity Genetic: next generation sequence

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Validation Studies of Biomarkers for Precision Radiation Oncology in Locally Advanced Solid Tumors
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : October 8, 2021
Estimated Study Completion Date : October 8, 2021

Group/Cohort Intervention/treatment
non-smell cell lung cancer (NSCLC)
Advanced NSCLC patients receiving radiotherapy or chemo-radiotherapy
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.

Rectal cancer
Rectal cancer patients receiving neoadjuvant radiotherapy or chemo-radiotherapy
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.

Smell cell lung cancer (SCLC)
SCLC patients receiving radiotherapy or chemo-radiotherapy
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.

Esophageal cancer
Esophageal cancer patients receiving radiotherapy or chemo-radiotherapy
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.

Cervical cancer
Cervical cancer patients receiving radiotherapy or chemo-radiotherapy
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.

Liver cancer
Liver cancer atients receiving radiotherapy or chemo-radiotherapy
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.




Primary Outcome Measures :
  1. TTP [ Time Frame: 2 years ]
    Time to progression

  2. OS [ Time Frame: 2 years ]
    Time to death


Biospecimen Retention:   Samples With DNA
tumor biopsy samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in the study with locally advanced solid tumors undergoing conventional fractionation or preoperative neoadjuvant radiotherapy (except stage IV patients and stage I patients to be treated with SBRT), including lung cancer, esophageal cancer, rectal cancer (neoadjuvant), cervical cancer, nasopharyngeal carcinoma and liver cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110223


Contacts
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Contact: Shuanghu Yuan Ph.D +8613853106916 yuanshuanghu@sina.com
Contact: Yong M Shao, Ph.D 025-58461736 yang.shao@geneseeq.com

Locations
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China, Shandong
Shandong Cancer Hospital and Institute Recruiting
Jinan, Shandong, China, 250117
Contact: Jinming Yu    8653167626891      
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
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Principal Investigator: Jinming Yu, Ph.D Shandong Cancer Hospital
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Responsible Party: Jinming Yu, President, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT04110223    
Other Study ID Numbers: GBRT-043
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jinming Yu, Shandong Cancer Hospital and Institute:
radiotherapy
radiosensitivity
radiation toxity
NGS