To assess whether ctDNA can be detected in PLF using the mFAST-SeqS method in a prospective cohort of patients with GC/GEJC who undergo a DLS.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is ability the mFast-SeqS technique to
detect ctDNA in patients with GC/GEJC.
Secondary outcome
Determine the test characteristics of the mFAST-SeqS method in PLF by analyzing
non-cancer and tumor-positive controls;
Concordance of detection rate of peritoneal dissemination between aneuploidy
and conventional methods (visual inspection and cytology);
Background summary
To ensure the appropriate treatment strategy for gastric cancer, various
methods are employed to determine clinical disease stage. Peritoneal metastases
are common in gastric/GEJ cancer, but accurately detecting these peritoneal
metastasis using conventional imaging techniques remains challenging. To
increase the sensitivity of staging when gastric/GEJ cancer appears resectable
on CT imaging, a diagnostic peritoneal staging laparoscopy (DLS) is performed.
During DLS, the abdominal cavity is inspected for the presence of macroscopic
peritoneal metastasis. Furthermore, a peritoneal lavage with saline is
performed, and the collected peritoneal lavage fluid (PLF) is examined by a
pathologist for the presence of cancer cells. However, the sensitivity of this
cytological evaluation is limited, and as a result of false negative results,
patients currently unjustly undergo treatment with curative intent, exposing
them to the risks and side-effects of surgery and intensive perioperative
chemotherapy. A more sensitive technique to detect peritoneal metastases during
staging would lead to better personalized treatment; less toxic palliative
treatment, or more intensive peritoneum-directed therapy in a trial setting in
selected patients.
A more sensitive diagnostic tool to detect peritoneal metastasis compared to
conventional cytology and imaging techniques may be the detection of ctDNA. One
way to detect ctDNA is by assessing aneuploidy, as its presence reflects the
fraction of circulating tumor DNA within cell-free DNA.
Study objective
To assess whether ctDNA can be detected in PLF using the mFAST-SeqS method in a
prospective cohort of patients with GC/GEJC who undergo a DLS.
Study design
prospective biomarker study
Study burden and risks
Collection of additional peritoneal lavage fluid is considered safe, and there
are no additional risks to collection of additional peritoneal lavage fluid, or
blood withdrawal.The risks associated with participation for both gastric-
/gastroesophageal junction cancer patients as non-cancer controls are
considered negligible. All safety measures and procedures will be performed
according to local guidelines.
dr. Molenwaterplein 40
Rotterdam 3015GD
NL
dr. Molenwaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
GC/GEJC patients:
o Patients who will undergo DLS for GC/GEJC;
o Age >=18 years old;
o Written informed consent according to the ICH-GCP and national/local
regulations.
non-cancer controls:
o Operable patients who will undergo a planned diagnostic laparoscopy for a
benign indica-tion bariatric or gallbladder disease);
o Age >=18 years old;
o Written informed consent according to the ICH-GCP and national/local
regulations.
Exclusion criteria
GC/GEJC patients:
o Language difficulty, dementia or altered mental status prohibiting the
under-standing and giving of informed consent.
non-cancer controls:
o Active inflammation or infection;
o Subjects with previous malignancies are excluded unless a complete remission
was achieved at least 5 years prior to study entry (exceptions include but are
not limited to, non-melanoma skin cancers; in situ bladder cancer, or in situ
co-lon cancers; in situ cervical cancers/dysplasia; or breast carcinoma in
situ).
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 | NCT06308510 |
| CCMO | NL86198.078.24 |