RECRUITING

Study of Individuals Affected With Hypoplasminogenemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an Investigator initiated retrospective and prospective single cohort study. The study will utilize an international registry and develop a specimen biobank to provide an improved understanding of the natural history of hyposplasminogenemia, to elucidate the heterogeneity of phenotypic expression, identify markers to predict disease course, and inform improved therapeutic modalities

Official Title

Hypoplasminogenemia: An International RetroSpecTive and PrOspective CohoRt StudY (HISTORY)

Quick Facts

Study Start:2018-12-18

Study Completion:2027-04-19

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03797495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed informed consent and assent as applicable (Appendix 1) 2. A. Males or females with type 1 PD diagnosed locally with plasminogen activity levels \<50% OR B. First degree family members of a person diagnosed with type 1 PD (includes parents, siblings, half-siblings) 3. All ages included 4. Available clinical history and treatment for at least 1 year prior to entry except for infants \< 1 year of age 5. Willingness to provide samples for analysis including DNA, plasma etc. 6. Willingness to participate in prospective follow-up for up to 3 years	1. Previous organ transplant recipient 2. Any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol 3. Refuses to provide informed consent 4. Special patient populations, including prisoners or, are deemed medically or cognitively unsuitable for research by their treating physician 5. Inability to obtain a blood sample due to poor or limited venous access

Inclusion Criteria

Exclusion Criteria

1. Signed informed consent and assent as applicable (Appendix 1)
2. A. Males or females with type 1 PD diagnosed locally with plasminogen activity levels \<50% OR B. First degree family members of a person diagnosed with type 1 PD (includes parents, siblings, half-siblings)
3. All ages included
4. Available clinical history and treatment for at least 1 year prior to entry except for infants \< 1 year of age
5. Willingness to provide samples for analysis including DNA, plasma etc.
6. Willingness to participate in prospective follow-up for up to 3 years

1. Previous organ transplant recipient
2. Any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol
3. Refuses to provide informed consent
4. Special patient populations, including prisoners or, are deemed medically or cognitively unsuitable for research by their treating physician
5. Inability to obtain a blood sample due to poor or limited venous access

Contacts and Locations

Study Contact

Amy D Shapiro, MD

CONTACT

317-871-0000

ashapiro@ihtc.org

Charles Nakar, MD

CONTACT

317-871-0000

cnakar@ihtc.org

Principal Investigator

Amy D Shapiro, MD

PRINCIPAL_INVESTIGATOR

Indiana Hemophilia &Thrombosis Center, Inc.

Flora Peyvandi, MD, PhD

PRINCIPAL_INVESTIGATOR

Univeristy of Milan

Study Locations (Sites)

Rush University Medical Center

Chicago, Illinois, 60612

United States

Indiana Hemophila @Thrombosis Center

Indianapolis, Indiana, 46260

United States

Stony Brook University | Stony Brook Medicine

East Setauket, New York, 11733

United States

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, 15213

United States

Vanderbilt Children's Hematology-Oncology

Nashville, Tennessee, 37232

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Seattle Children's Hospital

Seattle, Washington, 98105-3901

United States

Collaborators and Investigators

Sponsor: Indiana Hemophilia &Thrombosis Center, Inc.

Amy D Shapiro, MD, PRINCIPAL_INVESTIGATOR, Indiana Hemophilia &Thrombosis Center, Inc.
Flora Peyvandi, MD, PhD, PRINCIPAL_INVESTIGATOR, Univeristy of Milan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-18

Study Completion Date2027-04-19

Study Record Updates

Study Start Date2018-12-18

Study Completion Date2027-04-19

Terms related to this study

Additional Relevant MeSH Terms

Plasminogen Deficiency