Cardiovascular DiseasesNCT07106879
Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.
An observational study of Cardiovascular Diseases and Metabolic Syndrome, run by Clindove Research LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome, Obesity
- What is being tested?
- Blood Work
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 1 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clindove Research LLC
Brooklyn, New York, 11221
Nelly Cohen, MD, 516-518-3239, study@clindoveresearch.com
Nelly Cohen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome, Obesity, Prediabetes, Mental Health Disorders, Endocrine Dysfunction
- Being tested
- Blood Work
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome, Obesity, Prediabetic State, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood WorkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants undergoing metabolic and/or psychiatric assessments through blood work and structured clinical evaluations, as outlined in the study protocol. Receives: Other: Blood Work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who express interest in industry-sponsored clinical research
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.
Measured: 5 years
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
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start30 Jul 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Clindove Research LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly Cohen, MD, Principal investigator, Clindove Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106879
- Sponsor's protocol ID
- METCOME062025
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-screening Survey for Metabolic, Cardiovascular, Obesity, Mental Health, and Endocrine Trial Eligibility (DOVE-MET-COME-100)
- ClinicalTrials.gov ID
- NCT07106879
- Acronym / sponsor ID
- METCOME062025
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome, Obesity, Prediabetes, Mental Health Disorders, Endocrine Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Clindove Research LLCUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Blood WorkParticipants undergoing metabolic and/or psychiatric assessments through blood work and structured clinical evaluations, as outlined in the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood WorkCollection 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. | Other | All Participants |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Clindove Research LLC WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nelly Cohen, MD principal investigator
Clindove Research LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Metabolic Syndrome, run by Clindove Research LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nelly Cohen, MD (516-518-3239, study@clindoveresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who express interest in industry-sponsored clinical research (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.