- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05410028
New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence
June 4, 2022 updated by: Peking Union Medical College Hospital
New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence Via Analysis of Immunoinflammation-related Protein Complexes in Blood
In this study, mass spectrometry was used to analyze immune inflammation-related protein complexes, post-translational modified glycopeptide omics and tumor-related metabolomics in serum, respectively, in order to find potential metabolic small molecule biomarkers or marker profiles that can be used for early diagnosis of cancer recurrence.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Time cohort study: patients with confirmed ovarian epithelial cancer at different time cutoff points before treatment, after surgery, during chemotherapy, and after chemotherapy, until clinically confirmed patients relapse.
At least 50 patients are expected to be enrolled.
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 Contact
- Name: Peng Peng, MD
- Phone Number: +86-13521361934
- Email: pengp1999@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Peng Peng
- Phone Number: +86-13521361934
- Email: pengp1999@163.com
-
-
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
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Before treatment, after surgery, during chemotherapy, and after chemotherapy, patients with confirmed ovarian epithelial cancer had different time cutoff points until clinically confirmed patients recurred.
Description
Inclusion Criteria:
- Female
- A diagnosed patient with epithelial ovarian cancer
- Age ≤ 70
Exclusion Criteria:
- Male
- Suffering from other malignant tumors
- Non-compliant patient
- Age above 70
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 |
|---|---|---|
|
Immune Inflammation-Related Protein Complexes
Time Frame: 2 years
|
The change of immune inflammation-related protein complexes
|
2 years
|
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)
March 3, 2022
Primary Completion (ANTICIPATED)
March 3, 2024
Study Completion (ANTICIPATED)
March 3, 2026
Study Registration Dates
First Submitted
June 4, 2022
First Submitted That Met QC Criteria
June 4, 2022
First Posted (ACTUAL)
June 8, 2022
Study Record Updates
Last Update Posted (ACTUAL)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 4, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Recurrence
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- PUMCH-OC2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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