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

Recruiting

• Conditions: Neoplasmata
• Interventions: Genetic: Isolation of tumor DNA

• Registration Number: NCT03019471
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Status Verified: 2023-03
• Primary Completion: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer	Isolation of tumor DNA	Isolate Tumor DNA from the patients blood.
Colorectal cancer	Isolation of tumor DNA	Isolate Tumor DNA from the patients blood.
Glioma	Isolation of tumor DNA	Isolate Tumor DNA from the patients blood.
Lung cancer	Isolation of tumor DNA	Isolate Tumor DNA from the patients blood.

Primary Outcome Measures

Name	Time	Method
ctDNA	One year	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

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands