- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04215861
Clinical Study on Raman Spectra of Blood, Saliva and Urine in Patients With Cancer Treated by Modern Therapy
December 31, 2019 updated by: The First Affiliated Hospital of Dalian Medical University
Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral.
Study Overview
Status
Unknown
Conditions
Detailed Description
Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected for Raman spectral analysis, which provided exploration for the prediction of efficacy, follow-up and prognosis according to the variation characteristics of Raman spectral
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Liaoning
-
Dalian, Liaoning, China, 116000
- Recruiting
- The First Affiliated Hospital of Dalian Medical University
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- 18-80 years old;
- The patient whose tumor (tissue or cell) was first diagnosed by pathology;
- Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;
- Have relevant indications for treatment and have no contraindications;
Description
Inclusion Criteria:
- 18-80 years old;
- The patient whose tumor (tissue or cell) was first diagnosed by pathology;
- Plan to receive routine clinical treatment: chemotherapy, radiotherapy, surgery, intervention, targeted therapy, traditional Chinese medicine treatment and biological immunotherapy;
- Have relevant indications for treatment and have no contraindications;
Exclusion Criteria:
- Severe or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, heart, liver or kidney diseases, etc.);
- Other circumstances considered inappropriate by the researcher to participate in the study;
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 |
---|---|---|
Raman spectra
Time Frame: the 1st day before operation
|
Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum
|
the 1st day before operation
|
Raman spectra
Time Frame: the 1st day after operation
|
Blood, saliva and urine samples of tumor patients on the day of admission and discharge were collected to analyze the signal changes of Raman spectrum
|
the 1st day after operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
overall survival
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
objective response rate
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 1, 2019
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
December 11, 2019
First Submitted That Met QC Criteria
December 31, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 31, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PJ-KS-KY-2019-135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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