NCT02821286

Brief Summary

This project intends the analysis and profiling of specific antibodies against major peanut allergens in peanut allergic individuals and molecular cloning of human antibodies against major peanut allergens.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

9.5 years

First QC Date

June 29, 2016

Last Update Submit

December 19, 2023

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

  • Analysis and profiling of specific antibodies against major peanut allergens in samples derived from peanut allergic patients.

    June 2016 to May 2018

Interventions

Observational studyOTHER

Blood sampling

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The project population includes patients of at least three years of age with a described history of peanut allergy and/or sensitization to peanut allergens (as evidenced by positive skin prick test or allergen-specific IgE testing).

You may qualify if:

  • Participants have a described clinical history of peanut allergy and/or are sensitized to peanut allergens (as evidenced by positive skin prick test and allergen-specific IgE testing)
  • Male and female subjects older than 3 years
  • Written informed consent

You may not qualify if:

  • age below three years
  • patients suffering from any disease where blood withdrawals might impact the patients' health status such as known anemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Full blood

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Observation

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share