- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05984017
A Non-interventional Study With Advanced Lung Squamous Cell Carcinoma
January 8, 2024 updated by: Yongchang Zhang, Hunan Province Tumor Hospital
A Non-interventional Study and Its Clinical Relevance With Advanced Lung Squamous Cell Carcinoma
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective.
This study does not intend to intervene the current medical practice of the recruited patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
130
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: Nong Yang, MD
- Phone Number: +8613873123436 +8613055193557
- Email: yangnong0217@163.com
Study Contact Backup
- Name: Yongchang C Zhang, MD
- Phone Number: 7+861383123436 +8613873123436
- Email: zhangyongchang@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Yongchang Zhang
-
Contact:
- Yongchang Yongchang Zhang, MD
- Phone Number: +8613873123436 +8613873123436
- Email: zhangyongchang@csu.edu.cn
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
advanced or metastatic (stage IV) lung squamous cell carcinoma
Description
Inclusion Criteria:
- Patients must be ≥18 years.
- Provision of fully informed consent prior to any study specific procedures.
- Advanced or metastatic lung squamous cell carcinoma confirmed by histology or cytology.
- According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.
Exclusion Criteria:
- None
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival
Time Frame: 2 years
|
From registration onto that step until death, or censored at the date of last contact.
|
2 years
|
Overall survival
Time Frame: 2 years
|
From registration onto that step until death, or censored at the date of last contact.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital
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 (Actual)
July 1, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
July 31, 2023
First Posted (Actual)
August 9, 2023
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 8, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1701 RWS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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