Prospective Collection of Whole Blood From Active Non-Sma... | NCT05669105

Studies
Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research

NCT05669105

Sponsor

Sanguine Biosciences

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Specimen sample

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

Nov 2023

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

Feb 19, 2022Actual

Primary Completion Date

Mar 31, 2024Estimated

Completion Date

Mar 31, 2024Estimated

First Submitted Date

Dec 13, 2022

First Submission Date that Met QC Criteria

Dec 28, 2022

First Posted Date

Dec 30, 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

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

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

The study objective is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with active lung cancer to investigate the immune response to develop treatments and therapies.

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

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
Specimen sample	Diagnostic Test	Participants will have up to 100 mL of whole blood collected.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biospecimen & Clinical Data Collection	The primary objective is to collect 2000 whole blood samples from subjects who are diagnosed with active lung cancer. The purpose of this study is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with various active lung cancers so that investigations can analyze how the immune response can take place, and aid in understanding active lung cancer biomarkers for future early diagnosis and treatment options.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants willing and able to provide written informed consent
Participants are willing and able to provide appropriate photo identification
Participant's age 18 - 100 years old
Participants diagnosed with active non-small cell lung cancer (Adenocarcinoma or Squamous Cell only. All stages are acceptable.)
Participants must have associated tissue biomarker data (EFGR and MET mutations) in their medical records

Exclusion Criteria:

Participants who are pregnant or nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation defined as 250 mL in the last month or 500 mL in the previous two months
Participants currently enrolled in a clinical trial
Participants currently in remission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

The study will enroll up to 200 participants. Recruitment will occur through Sanguine advertisements, partnerships with cancer foundations, and cancer centers. Participants may be contacted for future studies.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Goslin	Contact	(818) 583-8844		tgoslin@sanguinebio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanguine Biosciences	Recruiting	Waltham	Massachusetts	02451	United States

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided