Human Phenotype Project Study Protocol | NCT05817734

Studies
Human Phenotype Project Study Protocol

NCT05817734

Sponsor

Weizmann Institute of Science

Status

Recruiting

Last Update Posted

Jul 16, 2024Actual

Enrollment

30,000Estimated

Phase

Not provided

Conditions

Adult Disease

Interventions

Not provided

Countries

Israel

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

Jul 2024

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

Oct 1, 2018Actual

Primary Completion Date

Dec 31, 2045Estimated

Completion Date

Dec 31, 2045Estimated

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Apr 16, 2023

First Posted Date

Apr 18, 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

Jul 14, 2024

Last Update Posted Date

Jul 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eran Segal, Prof. Eran Segal, PI at the department of computer science and applied math, Weizmann Institute of SciencePrincipal Investigator

Lead Sponsor

Weizmann Institute of ScienceOTHER

Collaborators

Not provided

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 is a prospective study aimed at recruiting 30,000 individuals, aged 40-70 years old, and following them longitudinally for 25 years with repeated measurements. The basic follow-up frame will include a visit to the Clinical Test Center (CTC) every two years and a phone interview every other year (on uneven years). Sample collection and biobanking will be performed every two years and online questionnaires will be filled out on an annual basis.

The primary goals are to study the variation observed across different individuals in disease susceptibility, clinical phenotypes, and therapeutic responses. The study aims at studying the complex interplay and relative contribution of different omics, physiological characteristics and lifestyle on disease pathogenesis and progression and to evaluate how these effects are mediated.

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

30,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adult disease	Development of medical conditions based on participant's self-reporting coded to ICD11.	25 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18+, males and females.

Exclusion Criteria:

Pregnancy.
Mentally disabled or in general legally non-competent.
Prisoner or soldier. Soldiers: mandatory service only
Active cancer
Fertility Treatments (current)
Hepatitis ( B, C), chronic or acute
HIV
Liver cirrhosis
Dialysis
Unstable medical conditions

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

General volunteering population who can freely register for the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eran Segal, Prof.	Contact	972-8-9343266		Eran.Segal@weizmann.ac.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weizmann institute of science	Recruiting	Rehovot			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39501340	Derived	Rein M, Elkan M, Godneva A, Dolev NC, Segal E. Sex-specific dietary habits and their association with weight change in healthy adults. BMC Med. 2024 Nov 6;22(1):512. doi: 10.1186/s12916-024-03730-3.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms