Cohort Construction and Prognostic Model Construction for... | NCT06366802

Studies
Cohort Construction and Prognostic Model Construction for Multiple Myeloma

NCT06366802

Sponsor

The First Affiliated Hospital of Soochow University

Status

Active, not recruiting

Last Update Posted

Apr 16, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

Not provided

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

Jan 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

May 3, 2022Actual

Primary Completion Date

May 2, 2027Estimated

Completion Date

May 2, 2027Estimated

First Submitted Date

Feb 1, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 16, 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

Apr 10, 2024

Last Update Posted Date

Apr 16, 2024Actual

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

Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes.

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

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival is defined as the time from being treated to death from any cause.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival(PFS)	Progression-free survival (PFS) is defined as the time from being treated to disease progression or death from any cause.	5years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were diagnosed as multiple myeloma from January 1, 2008 (the diagnostic criteria are based on "Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020)").

Exclusion Criteria:

Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Newly diagnosed MM patients admitted to the First Affiliated Hospital of Soochow University

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Soochow University		Suzhou	Jiangsu	215006	China

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided