Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood Work.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Metabolic Syndrome, Obesity, Prediabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pre-screening Survey for Metabolic, Cardiovascular, Obesity, Mental Health, and Endocrine Trial Eligibility (DOVE-MET-COME-100)
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Number of participants who express interest in industry-sponsored clinical research [Time frame: 5 years]
Secondary outcome measures (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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Clindove Research LLC — Brooklyn
Identifiers
NCT: NCT07106879 · METCOME062025