A Biomarker Exploration Study of Precision Treatment in O... | NCT06483425

Studies
A Biomarker Exploration Study of Precision Treatment in Ovarian Cancer

NCT06483425

Sponsor

Tongji Hospital

Status

Active, not recruiting

Last Update Posted

Jul 3, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Ovarian Cancer
Biomarker

Interventions

Sequencing of DNA, RNA, and Proteins

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

Jun 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2028Estimated

First Submitted Date

Jun 24, 2024

First Submission Date that Met QC Criteria

Jun 27, 2024

First Posted Date

Jul 3, 2024Actual

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 27, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This clinical trial aims to investigate the role of biomarkers in guiding precision treatment for ovarian cancer. The study will explore the effectiveness of personalized treatment strategies based on specific biomarkers identified in ovarian cancer patients. By analyzing the correlation between biomarker profiles and treatment outcomes, the trial seeks to optimize treatment decisions and improve overall survival rates in ovarian cancer patients.

Detailed Description

Not provided

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ovarian cancer pateitns		Patients diagnosed with Ovarian cancer in Tongji Hospital, Wuhan.	Genetic: Sequencing of DNA, RNA, and Proteins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sequencing of DNA, RNA, and Proteins	Genetic	Sequencing of DNA, RNA, and Proteins for Tumor, Blood, Ascite, and other samples before and after treatment.	Ovarian cancer pateitns

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biomarker explorarion	Blood, tumor, and other samples should be sequenced by RNA-seq, Next-Generation Sequencing, or proteomics to identify specific biomarkers associated with treatment response and prognosis in ovarian cancer.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with ovarian cancer.
Willingness to undergo biomarker testing.
Ability to provide informed consent for participation in the study.

Exclusion Criteria:

Inability to comply with study requirements or follow-up visits.
Previous participation in a conflicting clinical trial.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Ovarian cancer patients.

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with Ovarian cancer, who are willing to participate in this study and agree to donate samples for sequencing could be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology		Wuhan	Hubei	430030	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

Intervention Browse Module

MeSH Terms

ID	Term
D012313	RNA
D011506	Proteins

Ancestor Terms

ID	Term
D009696	Nucleic Acids
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided