NCT04708639

Brief Summary

Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 19, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

January 12, 2021

Last Update Submit

January 30, 2021

Conditions

Lung CancerALK Gene MutationResistance, DiseaseMutation

Outcome Measures

Primary Outcomes (2)

  • PFS on alectinib

    time from initiation of treatment to progression

    46 month

  • mechanism of resistance

    ctDNA to establish resistance mechanisms to alectinib treatment

    15.2 month

Interventions

AlectinibDRUG

Use of ctDNA to establish response and resistance to alectinib.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All newly diagnosed ALK translocated lung cancer adenocarcinomas.

You may qualify if:

  • Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
  • Written (personally dated and signed) informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA from blood samples

MeSH Terms

Conditions

Lung NeoplasmsDisease Resistance

Interventions

alectinib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Meldgaard, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

June 19, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2025

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

DK(1)