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Genomic Study of Relapse Esophageal Cancer After Radiotherapy

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ClinicalTrials.gov Identifier: NCT04694391
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
M.D. Anderson Cancer Center
Nantong University
Jiangsu Cancer Institute & Hospital
Henan Cancer Hospital
Ningbo No.2 Hospital
Taihe Hospital
Taian Cancer Hospital
Information provided by (Responsible Party):
Fudan University

Brief Summary:
Radiotherapy plays an important role in multidisciplinary treatment of esophageal cancer. However, about half patients received radiotherapy occurred relapse. Once relapse occurred, there is no better treatment strategy. Genomic study of relapsed esophageal cancer is seldom. So the investigators attempt to collect relapsed tissue to conduct with whole exome sequencing in order to investigate the genome landscape of recurrence esophageal cancer.

Condition or disease Intervention/treatment
Gene Mutation-Related Cancer Esophageal Cancer Radiation Exposure Genetic: whole exome sequence

Detailed Description:

Tumor tissue of patients received radiotherapy with diagnosis of recurrence between Jan 1, 2010 and Dec 1, 2020 were collected retrospectively. Recurrence tumor tissue is collected between Dec 31, 2020 and Dec 31, 2022 prospectively. Blood and preradiotherapy tumor tissue were also collected to be as contrast. A total of 100 paired blood, preradiotherapy tumor tissue and relapse tumor tissue were collected. What is more, a total of 100 paired blood and preradiotherapy tumor tissue with diagnosis of no recurrence were collected. All samples were conducted with whole exome sequencing.

Here the investigators define recurrence period as within 2 years and no recurrence period as more than 3 years after radiotherapy.

Criteria of relapse: (1) pathologic diagnosis is squamous carcinoma before radiotherapy;(2) received radiotherapy; (3)pathologic diagnosis is also squamous carcinoma after radiotherapy; (4) clinical symptoms including feeding obstruction etc; (5) imaging evidence showed disease progression.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genomic Study of Relapse Esophageal Cancer After Radiotherapy
Actual Study Start Date : September 14, 2012
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Recurrence
The period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy.
Genetic: whole exome sequence
To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.

No recurrence
The period was more than 3 years after radiotherapy and no recurrence signs were observed.
Genetic: whole exome sequence
To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.




Primary Outcome Measures :
  1. genomic characteristics of relapsed esophageal cancer [ Time Frame: through study completion, an average of 1 year ]
    gene mutations, copy number variants


Biospecimen Retention:   Samples With DNA
DNA was extracted from all samples to conduct exome sequence. The investigators attempt to seek genomic characteristics of relapsed esophageal cancer after radiotherapy.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Recurrence group: 100 paired relapsed tumor tissue,blood and preradiotherapy tumor tissue within 2 years after radiotherapy were collected.

No recurrence group:100 paired blood and preradiotherapy tumor tissue with more than 3 years after radiotherapy were collected

Criteria

Inclusion Criteria:

  1. pathologic diagnosis is squamous cell carcinoma before radiotherapy;
  2. pathologic diagnosis is squamous cell carcinoma after radiotherapy;
  3. received radiotherapy
  4. clinical symptoms including dysphagia, feeding obstruction, etc
  5. image evidence showed disease progression
  6. the period of recurrence was within 2 years after radiotherapy

Exclusion Criteria:

  1. pathologic diagnosis is not squamous cell carcinoma before radiotherapy;
  2. pathologic diagnosis is not squamous cell carcinoma after radiotherapy
  3. not received radiotherapy
  4. the period of recurrence was more than 2 years after radiotherapy
  5. the period of no recurrence was within 3 years after radiotherapy

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): NCT04694391


Contacts
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Contact: Kuaile Zhao, doctor 18017312534 kuaile_z@sina.com
Contact: Jiaying Deng, doctor 18317088158 dengjiaying3@sina.com

Locations
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China
Fudan university shanghai cancer center Recruiting
Shanghai, China, 200032
Contact: Kuaile Zhao, doctor    18017312534    kuaile_z@sina.com   
Contact: Jiaying Deng, doctor    18317088158    dengjiaying3@sina.com   
Sponsors and Collaborators
Fudan University
M.D. Anderson Cancer Center
Nantong University
Jiangsu Cancer Institute & Hospital
Henan Cancer Hospital
Ningbo No.2 Hospital
Taihe Hospital
Taian Cancer Hospital
Investigators
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Principal Investigator: Kuaile Zhao, doctor Fudan University
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Responsible Party: Fudan University
ClinicalTrials.gov Identifier: NCT04694391    
Other Study ID Numbers: ESO-shanghai 6
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
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
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases