Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients (MonAlec)

January 30, 2021 updated by: Peter Meldgaard, Aarhus University Hospital
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The purpose and objectives of the non-interventional study with primary data collection is

  • To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
  • To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
  • To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All newly diagnosed ALK translocated lung cancer adenocarcinomas.

Description

Inclusion Criteria:

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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS on alectinib
Time Frame: 46 month
time from initiation of treatment to progression
46 month
mechanism of resistance
Time Frame: 15.2 month
ctDNA to establish resistance mechanisms to alectinib treatment
15.2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Peter Meldgaard, MD, PhD, Aarhus University Hospital

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 Major Dates

Study Start (Actual)

June 19, 2019

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2025

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML40920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All data will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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