The Use of Residual De-identified Specimens and/or Sample... | NCT06222164

Studies
The Use of Residual De-identified Specimens and/or Samples From Patients for Clinical Research

NCT06222164

Sponsor

Invivoscribe, Inc.

Status

Recruiting

Last Update Posted

May 4, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Hematologic Diseases

Interventions

Not provided

Countries

United States

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

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2024Actual

Primary Completion Date

Mar 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jan 15, 2024

First Submission Date that Met QC Criteria

Jan 15, 2024

First Posted Date

Jan 24, 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

May 2, 2025

Last Update Posted Date

May 4, 2025Actual

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

Acquire residual human specimens and/or samples from patient samples which were sent for testing at LabPMM, LLC for Clinical Research

Detailed Description

Residual specimen/sample collection study where peripheral blood (PB), bone marrow (BM), genomic (gDNA), and/or formalin-fixed paraffin-embedded tissue (FFPE) specimens/samples are obtained from patient samples sent to LabPMM, LLC for clinical testing. Samples may be used for Clinical Research at LabPMM, LLC or at partner institutions

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
Residual Specimens		Residual specimen/sample collection study where peripheral blood (PB), bone marrow (BM), genomic (gDNA), and/or formalin-fixed paraffin-embedded tissue (FFPE) specimens/samples are obtained from patient samples sent to LabPMM, LLC for clinical testing.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enrollment	N=2000	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Specimen/sample, peripheral blood (PB), bone marrow (BM), genomic DNA (gDNA) and/or formalin-fixed paraffin-embedded tissue (FFPE) from patients whose specimens/samples have been sent to LabPMM for clinical testing
Donor Age ≥ 18 years

Exclusion Criteria:

Sample/specimen has been obtained from a third-party vendor with a Materials Transfer Agreement (MTA) on file with LabPMM
The specimens/samples have previously been enrolled in a clinical study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Specimen/sample, peripheral blood (PB), bone marrow (BM), genomic DNA (gDNA) and/or formalin-fixed paraffin-embedded tissue (FFPE) from patients whose specimens/samples have been sent to LabPMM for clinical testing

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew Schut	Contact	+1 858.224.6600		aschut@invivoscribe.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LabPMM	Recruiting	San Diego	California	92121	United States

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Study uses residual de-identified human samples

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006402	Hematologic Diseases

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description