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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorClindove Research LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Work

    Other intervention

    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.

Treatment groups

7,000 Participants
are divided into 1 treatment group
Group A: All Participants1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
5 years

Other outcomes

Sponsors and contacts

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