Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.

August 11, 2025 updated by: Clindove Research LLC

Pre-screening Survey for Metabolic, Cardiovascular, Obesity, Mental Health, and Endocrine Trial Eligibility (DOVE-MET-COME-100)

DOVE-MET-COME-100 is a single site prescreening survey study designed to identify adults who may be eligible for future industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, current health conditions and symptoms. The study team may also collect basic health information, including vital signs, urine drug tests, blood samples and pregnancy tests (if applicable). A physician will review each participant's medical history in a one-on-one interview to assess potential fit for upcoming trials. If needed, the doctor may contact the participant's current doctors or pharmacies to gather more information for eligibility review.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible participants will undergo screening procedures including laboratory assessments and health questionnaires to determine their suitability for further evaluation in metabolic and/or psychiatric sub-studies. The study does not include any investigational intervention.

Study Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11221
        • Recruiting
        • Clindove Research LLC
        • Principal Investigator:
          • Nelly Cohen, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This study will enroll participants of any sex, aged 18 and over from a general outpatient population, including both self-referred individuals and those referred by healthcare providers. Participants will undergo metabolic and/or psychiatric evaluations through structured interviews and blood-based biomarker assessments. Individuals interested in participating in an industry-sponsored clinical trial for investigational products targeting cardiovascular, obesity, or endocrine conditions will be screened for clinical suitability. Eligible participants may present with symptoms related to metabolic or psychiatric conditions, or both.

Description

Inclusion Criteria:

  • Any participant of age 18 years and over
  • Who are willing to provide informed consent and participate in the pre-screening study and comply with study procedures.

Exclusion Criteria:

  • Pregnant or breastfeeding individuals
  • Individuals having severe cognitive impairment or inability to provide informed consent
  • Individuals having acute psychiatric emergencies requiring immediate intervention/hospitalization
  • Individuals who are currently participating in another research study that conflicts with pre-screening data collection
  • Individuals having known history of drug/alcohol misuse
  • Individuals having medical conditions that, in the investigator's opinion, could compromise the integrity of the screening process or pose significant risks to the participant's health.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
Participants undergoing metabolic and/or psychiatric assessments through blood work and structured clinical evaluations, as outlined in the study protocol.
Other: Blood Work
Collection of blood samples for metabolic and other necessary biomarker analysis, including Hemoglobin A1c (HbA1c), Lipid Panel, Liver and Kidney function tests and other protocol-defined assays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who express interest in industry-sponsored clinical research
Time Frame: 5 years
The number of participants who express interest in industry-sponsored clinical research in each of the following therapeutic areas: cardiovascular, endocrine, metabolic and mental health disorder.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of a systematically curated and structured electronic database of pre-screened individuals, annotated with metabolic, cardiovascular, endocrine, and psychiatric risk factors
Time Frame: 5 years
Development of a systematically curated and structured electronic database of pre-screened individuals, annotated with metabolic, cardiovascular, endocrine, and psychiatric risk factors, for the purpose of streamlined matching and recruitment into future interventional trials. This will include demographic, clinical, laboratory, and mental health data with longitudinal tracking capacity for re-contact and follow-up.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clindove Research LLC

Investigators

  • Principal Investigator: Nelly Cohen, MD, Clindove Research LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

August 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METCOME062025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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