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At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931644
Recruitment Status : Recruiting
First Posted : August 29, 2013
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanguine Biosciences

Tracking Information
First Submitted Date August 23, 2013
First Posted Date August 29, 2013
Last Update Posted Date October 8, 2019
Study Start Date July 2013
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 26, 2013)
Biospecimen & Clinical Data Collection [ Time Frame: 10 years ]
To collect enough biospecimens and associated clinical data to allow researchers to come to statistically relevant scientific results
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01931644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
Official Title A Multi-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
Brief Summary We are the missing link in clinical trials, connecting patients and researchers seamlessly and conveniently using a mobile health platform to advance medical research. We make it easy for patients to contribute to research for medical conditions that matter most to them, regardless of their location or ability to travel.
Detailed Description This study will collect blood and other optionally donated tissue samples from people with all different types of health conditions, as well as healthy control samples, in order to provide biomedical researchers with quality biospecimens that are necessary in translating basic science research into clinically relevant information and technology.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, serum, plasma, PBMC, RNA, DNA, saliva, stool, hair, skin, CSF, synovial fuid, tumor tissue, urine
Sampling Method Probability Sample
Study Population Diagnosed with a health condition
Condition
  • All Diagnosed Health Conditions
  • ADD/ADHD
  • Alopecia Areata
  • Ankylosing Spondylitis
  • Asthma
  • Atopic Dermatitis Eczema
  • Beta Thalassemia
  • Bipolar Disorder
  • Breast Cancer
  • Celiac Disease
  • Cervical Cancer
  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Chronic Kidney Diseases
  • Chronic Obstructive Pulmonary Disease
  • Colon Cancer
  • Colorectal Cancer
  • Crohn's Disease
  • Cystic Fibrosis
  • Depression
  • Diabetes Mellitus
  • Duchenne Muscular Dystrophy
  • Endometriosis
  • Epilepsy
  • Facioscapulohumeral Muscular Dystrophy
  • G6PD Deficiency
  • General Anxiety Disorder
  • Hepatitis B
  • Hereditary Hemorrhagic Telangiectasia
  • HIV/AIDS
  • Human Papilloma Virus
  • Huntington's Disease
  • Idiopathic Thrombocytopenic Purpura
  • Insomnia
  • Kidney Cancer
  • Leukemia
  • Lung Cancer
  • Lupus Nephritis
  • Lymphoma
  • Melanoma
  • Multiple Myeloma
  • Multiple Sclerosis
  • Myositis
  • Myotonic Dystrophy
  • Ovarian Cancer
  • Pancreatic Cancer
  • Parkinson's Disease
  • Polycystic Kidney Diseases
  • Prostate Cancer
  • Psoriasis
  • Psoriatic Arthritis
  • Rosacea
  • Scleroderma
  • Sickle Cell Anemia
  • Sickle Cell Trait
  • Sjogren's Syndrome
  • Skin Cancer
  • Spinal Muscular Atrophy
  • Systemic Lupus Erythematosus
  • Thrombotic Thrombocytopenic Purpura
  • Trisomy 21
  • Ulcerative Colitis
Intervention Not Provided
Study Groups/Cohorts
  • Health Condition
    Collect blood and other optional biospecimens from participants with a diagnosed health condition
  • Healthy Control
    Collect blood and other optional biospecimens from participants that have not been diagnosed with a health condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 26, 2013)
20000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2040
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All adults 18-100 years old
  • Able to provide proof of diagnosis
  • Live in USA

Exclusion Criteria:

  • Younger than 18 years old
  • Receipt of blood products within 30 days of study blood collection
  • Receipt of investigational drug within 30 days of study blood collection
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Carolyn Bidwell 855.836.4759 study@sanguinebio.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01931644
Other Study ID Numbers SAN-BB-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanguine Biosciences
Study Sponsor Sanguine Biosciences
Collaborators Not Provided
Investigators
Principal Investigator: Houman Hemmati, MD Sanguine Biosciences
PRS Account Sanguine Biosciences
Verification Date October 2019