To evaluate the efficacy of a new tumor-agnostic ctDNA assay, the ctDNA estimator, to detect newly developing tumors in Lynch carriers.
ID
Source
Brief title
Condition
- Chromosomal abnormalities, gene alterations and gene variants
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The agreement between estimated ctDNA fractions and the presence of cancer.
Secondary outcome
N.A.
Background summary
Lynch Syndrome carriers have a predisposition to develop various types of
cancer, especially colorectal cancer (CRC) and endometrial cancer (EC). LS
patients are advised to undergo surveillance by colonoscopy every 2 year and
gynaecological surveillance. This surveillance is deemed burdensome and fails
to detect a small part of the developing CRCs and the majority of extra-colonic
cancers. To ensure prevention and early detection of cancer, a reliable and
accessible test is needed.
Recent studies have shown the potential of the detection of tumor-derived DNA
fragments (circulating tumor DNA; ctDNA). Various molecular characteristics can
be used to discriminate ctDNA from healthy circulating cell-free DNA. Current
ctDNA assays with the highest sensitivity and specificity to detect for example
minimal residual disease (MRD) after surgery are mostly tumor-informed, which
means prior information is needed from the tumor tissue about the molecular
alterations present. As this information is not available for the detection of
newly arising tumors, the aim of this study is to evaluate the use of an
optimized combination of tumor-agnostic ctDNA characteristics for the detection
of newly developing tumors.
Study objective
To evaluate the efficacy of a new tumor-agnostic ctDNA assay, the ctDNA
estimator, to detect newly developing tumors in Lynch carriers.
Study design
case-control study
Study burden and risks
Blood will be drawn only once, 3 tubes of 10 mL from LS carriers with a
recently diagnosed cancer, which will be combined with a routine hospital visit
when possible. The risk of blood collection by venepuncture is negligible
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
(suspect) LS carriers who:
- Have proven Lynch Syndrome (MMR gene or EpCAM mutation);
- Have been diagnosed with any form of cancer at time of inclusion, but have
had treatment yet
Exclusion criteria
(suspect) LS carriers who:
- Are unwilling to undergo extra blood sampling;
- Have no newly diagnosed tumors at time of inclusion;
- Have been treated for their tumor at time of inclusion.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87476.078.24 |