New Serum Biomarkers for Monitoring Early Diagnosis of Ov... | NCT05410028

Studies
New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence

NCT05410028

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Jun 8, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

No intervention in clinical treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2022Actual

Primary Completion Date

Mar 3, 2024Estimated

Completion Date

Mar 3, 2026Estimated

First Submitted Date

Jun 4, 2022

First Submission Date that Met QC Criteria

Jun 4, 2022

First Posted Date

Jun 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention in clinical treatment	Other	No intervention in clinical treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune Inflammation-Related Protein Complexes	The change of immune inflammation-related protein complexes	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peng Peng, MD	Contact	+86-13521361934		pengp1999@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital	Recruiting	Beijing	Beijing Municipality		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided