Non Invasive Cancer Test (NICT): a Proof of Principle Study. (NICT-NIPT-CA)

The investigators aim to collect tumor DNA out of blood of cancer patients. If this is successful this could lead to the development of a cancer test in blood in the future, which is less invasive than current diagnostic methods.

Study Overview

• Status: Recruiting
• Conditions: Neoplasmata
• Intervention / Treatment: Genetic: Isolation of tumor DNA

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Merryn M. Macville, Dr.; Phone Number: +31-43-3875843; Email: m.macville@mumc.nl
• Study Contact Backup: Name: Job J. Verdonschot, Drs.; Email: job-verdonschot@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HV
      • Recruiting
      • Maastricht University Medical Center
      • Contact: M. Eijck-Vievermans; Phone Number: +313876447; Email: margo.vievermans@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer, non-small cell lung cancer and anaplastic glioblastoma, before start of radiation therapy, chemoradiation or chemotherapy.
2. Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent

Description

Inclusion Criteria:

1. Patients with newly diagnosed local or metastatic breast cancer, colorectal cancer, non-small cell lung cancer and anaplastic glioblastoma, before start of radiation therapy, chemoradiation or chemotherapy.
2. Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent

Exclusion Criteria:

1. Patients with a history of malignant disease other than the disease under study, with an exception for adequately treated squamous cell carcinoma of the skin, basal cell carcinoma of the skin and in situ cervix carcinoma.
2. Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung cancer; Isolate Tumor DNA from the patients blood.	Genetic: Isolation of tumor DNA
Breast cancer; Isolate Tumor DNA from the patients blood.	Genetic: Isolation of tumor DNA
Colorectal cancer; Isolate Tumor DNA from the patients blood.	Genetic: Isolation of tumor DNA
Glioma; Isolate Tumor DNA from the patients blood.	Genetic: Isolation of tumor DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA	Demonstrate the presence or absence of ctDNA in patients plasma. Examine if there us a sufficient concentration of ctDNA in the plasma to reliably diagnose cancer and determine the CNV	One year

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Christine C. De Die-Smulders, Prof. dr., Clinical Geneticist in MUMC+

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimated): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NL55080.068.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No