Non-invasive blood test to detect tumor DNA in cancer patients.
Non Invasive Cancer Test (NICT): a Proof of Principle Study.
This project will try to detect tumor DNA in blood from adults newly diagnosed with breast, colorectal, non-small cell lung cancer, or anaplastic glioblastoma before they start treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT03019471 on ClinicalTrials.gov |
What this trial studies
Adults newly diagnosed with breast, colorectal, non-small cell lung cancer, or anaplastic glioblastoma will provide blood samples before beginning radiation, chemoradiation, or chemotherapy. Investigators will isolate circulating tumor DNA from those blood samples to determine whether tumor-derived DNA can be reliably detected. The study is observational and does not change participants' standard cancer care. Positive findings could support development of a less invasive blood-based cancer test for diagnosis or monitoring in the future.
Who should consider this trial
Good fit: Adults (over 18) with a new diagnosis of localized or metastatic breast cancer, colorectal cancer, non-small cell lung cancer, or anaplastic glioblastoma who have not yet started radiation or chemotherapy and can provide informed consent.
Not a fit: Patients with a history of other malignant disease (except adequately treated skin cancers or in situ cervical carcinoma) or who are pregnant are excluded and would not be eligible to participate or gain potential benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lead to a blood-based test that reduces the need for invasive tissue biopsies and makes cancer monitoring easier.
How similar studies have performed: Other circulating tumor DNA (liquid biopsy) studies have shown promising results across several cancer types, though sensitivity and clinical usefulness vary by tumor type and detection method.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Maastricht, Limburg
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Christine C. De Die-Smulders, Prof. dr. — Clinical Geneticist in MUMC+
- Study coordinator: Merryn M. Macville, Dr.
- Email: m.macville@mumc.nl
- Phone: +31-43-3875843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.