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NCT Number: NCT07106879

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

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.

Recruiting

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Key information

Conditions

Cardiovascular Diseases Body Weight Chronic Disease Chronic Kidney Disease (CKD) Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine Dysfunction Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Kidney Diseases Male Urogenital Diseases Mental Health Disorders Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Type 2 Diabetes Mellitus (T2DM) Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clindove Research LLC

Brooklyn, New York, 11221, United States

Location status: Recruiting

Location contact

Nelly Cohen, MD

CONTACT

[email protected]

516-518-3239

Nelly Cohen, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nelly Cohen, MD

CONTACT

[email protected]

516-518-3239

Sponsors and collaborators

Lead sponsor

Clindove Research LLC

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 6, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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