Non Invasive Cancer Test (NICT): a Proof of Principle Study. | NCT03019471

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

NCT03019471

Sponsor

Maastricht University Medical Center

Status

Recruiting

Last Update Posted

Oct 7, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Neoplasmata

Interventions

Isolation of tumor DNA

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 12, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2025

Last Update Posted Date

Oct 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isolation of tumor DNA	Genetic		Breast cancer Colorectal cancer Glioma Lung cancer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merryn M. Macville, Dr.	Contact	+31-43-3875843		m.macville@mumc.nl
Job J. Verdonschot, Drs.	Contact		+31-43-3877093	job-verdonschot@mumc.nl

Overall Officials

Name	Affiliation	Role
Christine C. De Die-Smulders, Prof. dr.	Clinical Geneticist in MUMC+	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center	Recruiting	Maastricht	Limburg	6229 HV	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided