Vincere Biobank Research Protocol | NCT05954299

Studies
Vincere Biobank Research Protocol

NCT05954299

Sponsor

Vincere Cancer Center

Status

Recruiting

Last Update Posted

Dec 7, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Cancer

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

Dec 2023

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

Jul 18, 2023Actual

Primary Completion Date

Dec 31, 2033Estimated

Completion Date

Dec 31, 2038Estimated

First Submitted Date

Jul 12, 2023

First Submission Date that Met QC Criteria

Jul 12, 2023

First Posted Date

Jul 20, 2023Actual

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

Dec 6, 2023

Last Update Posted Date

Dec 7, 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 Vincere Biobank aims to make quality biospecimens and associated clinical data available for research studies related to advancing medicine and improving care for patients, including cancer screening, treatment, and care.

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal		Participants and donor samples without disease (ex: non-cancer)
Disease state or condition		Participants and donor samples with known disease or condition (ex: cancer)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biobank	Collect quality biospecimens with associated clinical data for research studies related to improving medicine and care to the patient, including cancer screening, treatment, and care.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older; any gender
Able to donate a blood, urine, tissue, and/or other biospecimen sample
Able to provide informed consent to participate in the study

Exclusion Criteria:

Minors, under the age of 18 years
Individuals who lack the capacity to give informed consent

Accepts Healthy Volunteers

Yes

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

Adults age 18 years and older of any gender and demographic group, including both healthy participants and those with disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christine Lau, MD	Contact	480-306-5390		drlau@vincerecancer.com

Overall Officials

Name	Affiliation	Role
Vershalee Shukla, MD	Vincere Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vincere Cancer Center	Recruiting	Scottsdale	Arizona	85260	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided