Therefore the objective of this study is to test the feasibility of the detection of circulating tumor DNA of a variety of tumors in peripheral blood using a novel detection process.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is sensitivity and specificity of the novel ctDNA
detection process.
Secondary outcome
Not applicable
Background summary
Currently, malignant organ tumors are usually detected in a later stage with a
missed chance for a long-term cure. Therefore it is desirable to detect cancers
at early stages. Circulating tumor DNA (ctDNA) may serve as *liquid biopsy* for
detection, monitoring an potentially therapeutic decision making in certain
types of cancer. The method for detection has thus far been unreliable, however
a novel process has been developed, which allows detecting a wider set of
mutations at a higher sensitivity then conventional sequencing-based methods.
Study objective
Therefore the objective of this study is to test the feasibility of the
detection of circulating tumor DNA of a variety of tumors in peripheral blood
using a novel detection process.
Study design
Prospective case-matched cohort study comparing patients with cancer with
patients without a diagnosis of cancer.
Study burden and risks
Patient who choose to enter the study will have an additional blood sample
taken during a regular blood withdrawal moment, as part of the offered
treatment: surgery or (radio)chemotherapy. A possible risk might be that a
minor complication (hematoma, infection) due to the blood withdrawal will
partake. However, since the extra blood sample is taken during a regular blood
withdrawal moment, there is no additional risk when participants partake in
this study.
2632 Bevenue Ave 2120
Berkeley CA 94704
US
2632 Bevenue Ave 2120
Berkeley CA 94704
US
Listed location countries
Age
Inclusion criteria
Subjects of both cohorts must:
- Be of age * 18 years
- Provide written consent for study participation;Subjects of cohort 1 must:
- Have a diagnosis of one of the following malignancies in clinical stage 0 to IV: non-small lung cancer, gastric cancer, pancreatic adenocarcinoma, hepatocellular carcinoma, colorectal cancer, bladder cancer, prostate cancer, breast cancer, ovarian cancer, cervical cancer, adrenocortical cancer, breast cancer, ovarian cancer, cervical cancer, adrenocortical cancer, melanoma and leukemia.;Subjects of cohort 2 must:
- Are planned for surgery in the foreseeable future, to guarantee a blood sample.
Exclusion criteria
Subjects of cohort 1 must not:
- Have been treated for above diagnosed malignancy ;Subjects of cohort 2 must not
- Have been diagnosed or treated for a malignancy previously
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 |
|---|---|
| ClinicalTrials.gov | NCT03517332 |
| CCMO | NL66804.100.18 |