## Protocol Section
### Identification Module
**NCT ID:** NCT06412536

**Acronym:** SWIFT-CORE-101

**Brief Title:** Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility

**Official Title:** Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility (SWIFT-CORE-101)

#### Organization Study ID Info
**ID:** CORE042024
#### Organization
**Class:** NETWORK
**Full Name:** Brooklyn Clinical Research
### Status Module
#### Completion Date
**Date:** 2029-04-17

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-04-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-12

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Brooklyn Clinical Research

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** SWIFT-CORE-101 is a single site survey study designed to assess potential participants' eligibility to screen for industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, comorbidities, and current symptoms. Site staff may collect vital signs, urine drug screens, blood draws, and urine pregnancy tests. A doctor will review medical history with the participant to determine study suitability via clinical interview. The doctor may reach out to the patient's current treating physicians and pharmacies to determine eligibility for clinical trials.

### Conditions Module

**Conditions:**

- Cardiovascular Diseases

- Obesity

- PreDiabetes

- Diabetes Type 2

- Metabolic Syndrome

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 5 Years

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Blood work on some participants to review eligibility for future clinical trials

**Name:** Blood work

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Number of participants who are interested in industry-sponsored clinical research in each of the following therapeutic areas: cardiovascular, obesity, and endocrine.

**Measure:** Number of participants who are interested in industry-sponsored clinical research

**Time Frame:** 5 years

#### Secondary Outcomes

**Description:** Characteristics associated with patient populations interested in clinical trials stratified by demographics and therapeutic areas

**Measure:** Characteristics associated with patient populations interested in clinical trials

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed.
2. Participant is at least 18 years old.

Exclusion Criteria:

1. Participant is pregnant, breast-feeding, or planning to become pregnant.
2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
3. Moderate or severe substance use disorder within 90 days prior to screen
4. Any condition that in the investigator's opinion makes a participant unsuitable for the study.
5. Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** In year one of the program, we anticipate 4000 participants of any sex, age 18+, who have expressed interest in participating in an industry-sponsored clinical trial of an investigational product for indications in cardiovascular, obesity, and endocrine-related therapeutic areas will be screened for clinical appropriateness for a study trial.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** amushtaq@brooklynclinicalresearch.com

**Name:** Ammara Mushtaq, MD

**Phone:** 929-203-5879

**Role:** CONTACT

**Contact 2:**

**Email:** kazer@brooklynclinicalresearch.com

**Name:** Katherine Azer, MS

**Phone:** 929-332-7848

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Brooklyn

**Contacts:**

***Contact 1:***

- **Email:** amushtaq@brooklynclinicalresearch.com

- **Name:** Ammara Mushtaq, MD

- **Phone:** 929-203-5879

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ammara Mushtaq, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Brooklyn Clinical Research

**State:** New York

**Zip:** 11226

#### Overall Officials

**Official 1:**

**Affiliation:** Brooklyn Clinical Research

**Name:** Ammara Mushtaq, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-04-30

- Filename: ICF_000.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 281532

- Type Abbrev: ICF

- Upload Date: 2024-05-06T11:52

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000007333

- Term: Insulin Resistance

- ID: D000006946

- Term: Hyperinsulinism

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M14117

- Name: Prediabetic State

- Relevance: LOW

- As Found: Unknown

- ID: M20295

- Name: Glucose Intolerance

- Relevance: LOW

- As Found: Unknown

- ID: M23005

- Name: Metabolic Syndrome

- Relevance: HIGH

- As Found: Metabolic Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Type 2

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M10370

- Name: Insulin Resistance

- Relevance: LOW

- As Found: Unknown

- ID: M9997

- Name: Hyperinsulinism

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000009765

- Term: Obesity

- ID: D000024821

- Term: Metabolic Syndrome

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Misc Info Module

- Version Holder: 2024-05-31
