NCT03234764

Brief Summary

The purpose of this study is to evaluate the clinical usefulness of assessing specific human allergy antibodies and other immunologic parameters associated with the diagnosis, evolution, and management of allergic disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2017

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

July 26, 2017

Last Update Submit

February 14, 2018

Conditions

Food Allergy

Keywords

IgEAllergyToleranceImmunotherapyDesensitization

Outcome Measures

Primary Outcomes (1)

  • Immunological markers

    IgE, IgG4, T cells

    February 2027

Interventions

ImmunotherapyOTHER

Eligibility Criteria

Age6 Months - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center

You may qualify if:

  • Patients ages 6 months through 70 years who have previously undergone a food immunotherapy protocol only at our center.

You may not qualify if:

  • None. However, if a participant becomes pregnant, their clinic visit may be postponed until after delivery and/or lactation period. These subject can postpone visits for one year and choose to skip visits during pregnancy and another year after (if breastfeeding).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.

    PMID: 29296107BACKGROUND

  • Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.

    PMID: 29296108BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Sputum Buccal swab Saliva Urine Stool

MeSH Terms

Conditions

Food HypersensitivityHypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 31, 2017

Study Start

March 1, 2016

Primary Completion

December 18, 2017

Study Completion

December 18, 2017

Last Updated

February 19, 2018

Record last verified: 2018-02