Ovarian CancerNCT05410028
New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence
An observational study of Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2022to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Female
- A diagnosed patient with epithelial ovarian cancer
- Age ≤ 70
Who cannot join
- Male
- Suffering from other malignant tumors
- Non-compliant patient
- Age above 70
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Peng Peng, +86-13521361934, pengp1999@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- No intervention in clinical treatment
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in clinical treatmentOther
No intervention in clinical treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Inflammation-Related Protein Complexes
The change of immune inflammation-related protein complexes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start3 Mar 2022
- Primary completion3 Mar 2024 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410028
- Sponsor's protocol ID
- PUMCH-OC2
- Status last verified
- Mar 2022
- First submitted
- 4 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence Via Analysis of Immunoinflammation-related Protein Complexes in Blood
- ClinicalTrials.gov ID
- NCT05410028
- Acronym / sponsor ID
- PUMCH-OC2
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 3 Mar 2024 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female
- A diagnosed patient with epithelial ovarian cancer
- Age ≤ 70
Key exclusion criteria (4 listed)
- Male
- Suffering from other malignant tumors
- Non-compliant patient
- Age above 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention in clinical treatmentNo intervention in clinical treatment | Other | – |
Primary outcome
Immune Inflammation-Related Protein Complexes
Time frame: 2 years
The change of immune inflammation-related protein complexes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Peng, MD (+86-13521361934, pengp1999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Inflammation-Related Protein Complexes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.