RECRUITING

APOL1 Genotyping CTA Clinical Performance Study

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

Clinical Performance Study SP2024001, is a prospective, interventional study to assess the clinical performance of the APOL1 Genotyping Clinical Trial Assay (CTA) in the intended use population and environment. The study will use the APOL1 Genotyping CTA to test deoxyribonucleic acid (DNA) extracted from blood specimens to identify individuals who are homozygous or compound heterozygous for apolipoprotein L1 (APOL1) high-risk genotypes (G1 and G2).The individuals who are identified as being homozygous or compound heterozygous for the APOL1 high-risk genotypes are candidates for enrolment onto an pharmaceutical company-sponsored, Phase 2b clinical trial which is investigating the safety and efficacy of a synthetic antisense oligonucleotide (ASO) for the treatment of APOL1-mediated kidney disease (AMKD).

Official Title

A Prospective, Interventional Study to Assess the Clinical Performance of the APOL1 Genotyping Clinical Trial Assay in the Intended Use Population and Environment

Quick Facts

Study Start:2025-03-06
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06839833

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study participants must be identified as a potential candidate for the pharmaceutical company- sponsored clinical trial by their physician based on the clinical trial inclusion criteria.
  2. * Study participant has agreed to and signed the clinical trial Informed Consent Form (inclusive of risks related to the APOL1 Genotyping CTA).
  3. * The study participant's specimen must be distributed to the device test site accompanied by a complete Test Request Form signed by the appropriate clinical trial site personnel.
  4. * All participant specimens must meet predetermined specifications (e.g., undamaged, appropriate volume, appropriate specimen type, appropriate disease indication) for acceptance for testing by the device test site in accordance with established procedures.
  1. * Study participants will be excluded as a potential candidate for the pharmaceutical company -sponsored clinical trial by their physician based on the clinical trial exclusion criteria as assessed at screening visit 1.
  2. * The study participant has not agreed to and signed the (Clinical Trial) Informed Consent Form.
  3. * The study participant's specimen is distributed to the device test site without a complete Test Request Form.
  4. * The study participant's specimen did not meet predetermined specifications for acceptance for testing by the device test site in accordance with established procedures.

Contacts and Locations

Study Contact

Charlene Robb, MPharm PhD
CONTACT
00442838337575
ALDRegulatoryTeam@almacgroup.com
Ruth A Scott, BSc (Hons)
CONTACT
00442838337575
ALDRegulatoryTeam@almacgroup.com

Principal Investigator

Richard Kennedy, MD PhD FRCP
PRINCIPAL_INVESTIGATOR
Almac Diagnostic Services Ltd

Study Locations (Sites)

Almac Diagnostic Services LLC
Durham, North Carolina, 27704
United States

Collaborators and Investigators

Sponsor: Almac Diagnostic Services LLC

  • Richard Kennedy, MD PhD FRCP, PRINCIPAL_INVESTIGATOR, Almac Diagnostic Services Ltd

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 Date2025-03-06
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-03-06
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • APOL1-mediated Kidney Disease