Genomic Study of Relapse Esophageal Cancer After Radiotherapy

NCT ID: NCT04694391

Last Updated: 2021-01-26

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-14

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gene Mutation-Related Cancer Esophageal Cancer Radiation Exposure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Recurrence

The period of recurrence was within 2 years after radiotherapy. Pathologic diagnosis was squamous cell carcinoma same with preradiotherapy.

whole exome sequence

Intervention Type GENETIC

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.

whole exome sequence

Intervention Type GENETIC

To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.

Interventions

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whole exome sequence

To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.

Intervention Type GENETIC

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Nantong University

OTHER

Sponsor Role collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role collaborator

Taihe Hospital

OTHER

Sponsor Role collaborator

Taian Cancer Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuaile Zhao, doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan university shanghai cancer center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kuaile Zhao, doctor

Role: CONTACT

18017312534

Jiaying Deng, doctor

Role: CONTACT

18317088158

Facility Contacts

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Kuaile Zhao, doctor

Role: primary

18017312534

Jiaying Deng, doctor

Role: backup

18317088158

Other Identifiers

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ESO-shanghai 6

Identifier Type: -

Identifier Source: org_study_id

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