- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299622
Personalized Sequence for Thoracic, Esophageal, and H&N Cancer
March 18, 2021 updated by: Keunchil Park, Samsung Medical Center
Establishment of Personalized Cancer Medicine Using Samsung Cancer Sequencing Platform in Lung Cancer/Mediastinal Tumor/ Head & Neck/Esophageal Cancer/Rare Cancer (PerSeq: Personalized Sequence)
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly.
The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.
Study Overview
Detailed Description
To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Keunchil Park
- Phone Number: 822-3410-3459
- Email: kpark@skku.edu
Study Locations
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-
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Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
Contact:
- Keunchil Park, M.D., Ph.D.
- Phone Number: 822-3410-3450
- Email: kpark@skku.edu
-
Principal Investigator:
- Keunchil Park, M.D., Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
metastatic, histologically confirmed NSCLC, head & Neck Cancer, Esophageal cancer
Description
Inclusion Criteria:
- metastatic, histologically confirmed NSCLC, head & Neck Cancer, Esophageal cancer
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the spectrum of targetable genetic mutation in evaluated cancer specimens (for example, % of EGFR T790M mutation, BRAF mutation, or ALK mutation)
Time Frame: 3 years
|
The pattern of the tumor's molecular profiling in advanced thoracic (lung, esophagus, or tthymic) cancer
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
November 19, 2014
First Submitted That Met QC Criteria
November 20, 2014
First Posted (Estimate)
November 24, 2014
Study Record Updates
Last Update Posted (Actual)
March 19, 2021
Last Update Submitted That Met QC Criteria
March 18, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-10-112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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