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

NCT07106879 — Recruiting, 7000 participants, Clindove Research LLC

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

Registry	NCT07106879
Status	Recruiting
Study type	Observational
Enrollment	7000 (Estimated)
Sponsor	Clindove Research LLC (Other)
Conditions	Cardiovascular Diseases, Metabolic Syndrome, Obesity, Prediabetes, Mental Health Disorders, Endocrine Dysfunction, Type 2 Diabetes Mellitus (T2DM), Chronic Kidney Disease (CKD)
Interventions	Blood Work (Other)
Dates	start 2025-07-30, primary completion 2030-07-01 (estimated), completion 2030-12-01 (estimated), first posted 2025-08-06, last updated 2025-08-12
Locations	1 site in United States

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
All Participants		Other: Blood Work	Participants undergoing metabolic and/or psychiatric assessments through blood work and structured clinical evaluations, as outlined in the study protocol.

Blood Work (Other): 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.

+Outcome measures

Primary outcomes

Number of participants who express interest in industry-sponsored clinical research [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.

Secondary outcomes

Development of a systematically curated and structured electronic database of pre-screened individuals, annotated with metabolic, cardiovascular, endocrine, and psychiatric risk factors [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Clindove Research LLC	Brooklyn, New York	United States	Recruiting

+Study documents

Informed Consent Form (PDF, 2025-07-07)

+Investigators

Nelly Cohen, MD, Principal investigator, Clindove Research LLC