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Genomic Study of Relapse Esophageal Cancer After Radiotherapy

Genomic Study of Relapse Esophageal Cancer After Radiotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04694391
Enrollment
200
Registered
2021-01-05
Start date
2012-09-14
Completion date
2022-12-31
Last updated
2021-01-26

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

Conditions

Esophageal Cancer, Gene Mutation-Related Cancer, Radiation Exposure

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.

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.

Interventions

GENETICwhole exome sequence

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

Sponsors

M.D. Anderson Cancer Center
CollaboratorOTHER
Nantong University
CollaboratorOTHER
Jiangsu Cancer Institute & Hospital
CollaboratorOTHER
Henan Cancer Hospital
CollaboratorOTHER_GOV
Ningbo No.2 Hospital
CollaboratorOTHER
Taihe Hospital
CollaboratorOTHER
Taian Cancer Hospital
CollaboratorOTHER
Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
genomic characteristics of relapsed esophageal cancerthrough study completion, an average of 1 yeargene mutations, copy number variants

Countries

China

Contacts

Primary ContactKuaile Zhao, doctor
kuaile_z@sina.com18017312534
Backup ContactJiaying Deng, doctor
dengjiaying3@sina.com18317088158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026