RECRUITING

Systems Biology of Early Atopy

Conditions

Allergic Diseases Food Allergy Atopic Dermatitis birth cohort risk factors systems biology

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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

The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: * To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development and course of allergic diseases through age 3 years (or 6 years for those who choose to continue participation into SUNBEAM II), with an emphasis on atopic dermatitis and food allergy * To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes * To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development

Official Title

Systems Biology of Early Atopy

Quick Facts

Study Start:2021-03-18

Study Completion:2032-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04798079

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:0 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent 3. Pregnant at any stage 4. Planning to give birth at a study-site designated center 5. Agrees to enroll offspring into the study at birth 6. In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order 1. Age 18 years or older 2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent	1. Inability or unwillingness to comply with study protocol 2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment 3. Fetus has a major chromosomal anomaly 4. Plans to move and would not be available for in-person visits at a study site 5. Plans to give up her child for adoption at birth 6. Pregnancy is the result of an egg donation 1. Delivered earlier than 34 weeks of gestation 2. Sibling already enrolled 3. Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest 1. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment 1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment 2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian: * Agrees to meet the child's study requirements, and * Provides written informed consent for the child's continued participation. 3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older
2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent
3. Pregnant at any stage
4. Planning to give birth at a study-site designated center
5. Agrees to enroll offspring into the study at birth
6. In the case of multiple gestation, agrees to enroll only one child who will be selected by randomized birth order
1. Age 18 years or older
2. Able to understand the oral and written instructions associated with study visits and procedures and provide informed consent

1. Inability or unwillingness to comply with study protocol
2. Serious pregnancy complication (in the judgement of the investigator) prior to enrollment
3. Fetus has a major chromosomal anomaly
4. Plans to move and would not be available for in-person visits at a study site
5. Plans to give up her child for adoption at birth
6. Pregnancy is the result of an egg donation
1. Delivered earlier than 34 weeks of gestation
2. Sibling already enrolled
3. Born with a significant birth defect or medical condition, and in the judgment of the investigators, participation is not in the infant's best interest
1. Biological fathers who are unable or unwilling to comply with the study protocol as it pertains to the biological father's participation are not eligible for enrollment
1. At screening for enrollment of either the mother or the child, if the biological mother intends to give the infant up for adoption, neither the mother nor the child are eligible for enrollment
2. If the biological mother gives up legal guardianship of the child during the child's follow-up period, the child may remain enrolled as long as the new legal guardian:
* Agrees to meet the child's study requirements, and
* Provides written informed consent for the child's continued participation.
3. Throughout the protocol where it refers to the mother, father, or parent answering questionnaires about the child or collecting samples from the child and the child's primary home, the legal guardian who provides consent for the child's participation may complete those procedures

Contacts and Locations

Principal Investigator

Corinne Keet, MD,MS,PhD

STUDY_CHAIR

Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine

Scott H. Sicherer, MD

STUDY_CHAIR

Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

Sean N. Parker Center for Allergy & Asthma Research at Stanford University

Stanford, California, 94040

United States

National Jewish Health

Denver, Colorado, 80206

United States

Johns Hopkins Children's Center, Department of Allergy & Immunology

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital, Translational and Clinical Research Center

Boston, Massachusetts, 02114

United States

Henry Ford Health System, Division of Allergy and Immunology

Detroit, Michigan, 48202

United States

Kravis Children's Hospital, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology

Chapel Hill, North Carolina, 27599

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Vanderbilt University Medical Center Department of Pediatrics Division of Pediatric Allergy, Immunology, and Pulmonary Medicine

Nashville, Tennessee, 37232

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Corinne Keet, MD,MS,PhD, STUDY_CHAIR, Div.of Pediatric Allergy, Immunology and Rheumatology, Dept. of Pediatrics, Johns Hopkins School of Medicine
Scott H. Sicherer, MD, STUDY_CHAIR, Div. of Pediatric Allergy and Immunology, Jaffe Food Allergy Institute,Dept. of Pediatrics, Icahn School of Medicine at Mount Sinai

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 Date2021-03-18

Study Completion Date2032-03

Study Record Updates

Study Start Date2021-03-18

Study Completion Date2032-03

Terms related to this study

Keywords Provided by Researchers

birth cohort
risk factors
systems biology

Additional Relevant MeSH Terms

Allergic Diseases
Food Allergy
Atopic Dermatitis