Direct to Patient Minimal Risk Biospecimen and Data Collection Research

NCT07128966 | Recruiting

• 2 other identifiers: JB-MR-250225JB Direct to Participant
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to help researchers better understand health conditions and develop improved tests, treatments, and cures for diseases. Joined Bio collects health data, lifestyle information, biological samples, and feedback from participants and provides this to qualified research partners.

Conditions

Healthy; Lupus; Celiac; Kidney Disease; Chronic; Dermatologic

Keywords

biospecimen; rare disease; participant; registry

Outcome Measures

Primary Outcomes (1)

• Observation for biomarker identification

  There is no defined study outcome. Rather this is an observational study of multiple participant populations that hopes to identify new biomarkers, treatments and/or diagnostic applications.

  10 years

Study Arms (2)

Healthy participants

This is non-interventional, observational only research. Participants may be healthy. Participants will be invited to participate on a per-project basis, depending on the cohort requirements for the project.

Other: Observation

Participants with a condition

Participants may have a condition such as lupus, celiac, dermatitis or other condition. Participants will be invited to participate on a per-project basis, depending on the cohort requirements for the project.

Other: Observation

Interventions

Observation OTHER

This is non-interventional, observational only

Healthy participants; Participants with a condition

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outside of this protocol, Joined Bio is creating a network of individuals who are interested in participating in research. Individuals are recruited across a broad cross-section of ages, medical conditions, and geographic locations within the United States. These individuals voluntarily join the Joined Bio network, consent to share health information with Joined, and then securely transfer their health information to Joined Bio. All health information is stored in a de-identified manner (with the exception of dates of service, which are protected in accordance with HIPAA) and encrypted with Joined Bio holding re-identification keys. Joined Bio then searches its network of participants to see if there are matches to the research project. If there are matches, Joined Bio re-identifies the individual and reaches out to them to let them know that they match up to a research project and also to provide them with information about the research.

You may qualify if:

• Male or female, that are adults \[have reached the Age of Majority = aged 18 to 90 in most US states; aged 19-90 in Alabama or Nebraska; aged 21-90 in Mississippi or Puerto Rico\].
• Have reviewed and signed a consent or e-consent form for this study. If a person with diminished decision-making capacity, their Legally Authorized Representative has reviewed and signed the consent for on their behalf.
• Be willing to comply with all study procedures and be available for the duration of the study.
• Meets requirements of a current request for research participation (e.g. has previous diagnosis of a medical condition of interest or laboratory results within a specific range).
• Pregnant women may be enrolled in this study in accordance with 45 CFR Part 46 Subpart B.

You may not qualify if:

• Prisoners or children
• Unable to provide the requested biospecimen(s), data or feedback without placing the individual at risk.

Sponsors & Collaborators

• Joined Bio: lead

Study Sites (1)

Joined Bio

Lexington, Massachusetts, 02420, United States

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Minimal risk only: Blood hair, nail, skin scrapings urine, stool, sweat, tears uncannulated saliva; mucosal and skin cells collected by buccal scraping or mouth washings; sputum collected after saline mist nebulization; nasal swabs that are inserted no deeper than until resistance is met (i.e. are not inserted beyond the opening of the nasal cavity into the pharynx); cheek or throat swabs; vaginal swabs when no deeper than 4 inches or until resistance is met (i.e. do not go beyond the opening to the cervix); external genital swabs.

MeSH Terms

Conditions

Celiac Disease; Kidney Diseases; Bronchiolitis Obliterans Syndrome; Rare Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Chris Ianelli, MD

  Joined Bio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily L Hubbard, BS Biology

CONTACT

12567970003; ehubbard@joined.bio

Jill Mullan

CONTACT

jmullan@joined.bio

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2036
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)