NeoplasmataNICT-NIPT-CANCT03019471
Non Invasive Cancer Test (NICT): a Proof of Principle Study.
An observational study of Neoplasmata, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasmata
- What is being tested?
- Isolation of tumor DNA
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2016to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
- Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent
Who cannot join
- 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.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Job J. Verdonschot, Drs. contact
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HV
M. Eijck-Vievermans, +313876447, margo.vievermans@mumc.nl
About this study
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.
- Conditions
- Neoplasmata
- Being tested
- Isolation of tumor DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of tumor DNAGenetic
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Isolate Tumor DNA from the patients blood. Receives: Genetic: Isolation of tumor DNA | |
| Breast cancer | Isolate Tumor DNA from the patients blood. Receives: Genetic: Isolation of tumor DNA | |
| Colorectal cancer | Isolate Tumor DNA from the patients blood. Receives: Genetic: Isolation of tumor DNA | |
| Glioma | Isolate Tumor DNA from the patients blood. Receives: Genetic: Isolation of tumor DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start1 Mar 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmataStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine C. De Die-Smulders, Prof. dr., Principal investigator, Clinical Geneticist in MUMC+
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019471
- Sponsor's protocol ID
- NL55080.068.15
- Acronym
- NICT-NIPT-CA
- Status last verified
- May 2025
- First submitted
- 11 Jan 2017
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Cancer Test (NICT): a Proof of Principle Study.
- ClinicalTrials.gov ID
- NCT03019471
- Acronym / sponsor ID
- NICT-NIPT-CA / NL55080.068.15
- Conditions
- Neoplasmata
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Genetic: Isolation of tumor DNAIsolate Tumor DNA from the patients blood. |
| Breast cancer | – | Genetic: Isolation of tumor DNAIsolate Tumor DNA from the patients blood. |
| Colorectal cancer | – | Genetic: Isolation of tumor DNAIsolate Tumor DNA from the patients blood. |
| Glioma | – | Genetic: Isolation of tumor DNAIsolate Tumor DNA from the patients blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
- Patients age > 18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent
Key exclusion criteria (2 listed)
- 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.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolation of tumor DNA | Genetic | Breast cancer, Colorectal cancer, Glioma, Lung cancer |
Primary outcome
ctDNA
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Job J. Verdonschot, Drs. contact
Christine C. De Die-Smulders, Prof. dr. principal investigator
Clinical Geneticist in MUMC+
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasmata, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merryn M. Macville, Dr. (+31-43-3875843, m.macville@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.