Gastric CancerNCT06308510
Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer
An observational study of Gastric Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- collection additional peritoneal lavage fluid
- How many people
- 63 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Dec 2024to Jul 2028
- Phase
- Observational
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Gastric cancer patients: Patients who will undergo DLS for GC or GEJ carcinoma Non-cancer controls: Operable patients who will undergo a planned diagnostic laparoscopy for a benign indication (bariatric or gallbladder disease);
Who may be able to join
- Age ≥18 years old;
- Written informed consent according to the ICH-GCP and national/local regula-tions.
- Operable patients who will undergo a planned diagnostic laparoscopy for a benign indication bariatric or gallbladder disease);
- Age ≥18 years old;
- Written informed consent according to the ICH-GCP and national/local regulations.
Who cannot join
- Language difficulty, dementia or altered mental status prohibiting the under-standing and giving of informed consent.
- non-cancer controls:
- Active inflammation or infection;
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Niels Guchelaar contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, 3015GD
Jessie Huizer, Drs, +31107034523, t.j.huizer@erasmusmc.nl
Niels Guchelaar, n.guchelaar@erasmusmc.nl
About this study
Aneuploidy may be used as a more sensitive diagnostic tool to detect peritoneal metastasis compared to conventional cytology and imaging techniques. Our aim is to establish whether aneuploidy as detected in cfDNA (as a measure for ctDNA) in PLF of patients with GC may hold value as an additional staging and tumor evaluation method in GC patients.
Read the detailed description
To ensure the appropriate treatment strategy for gastric cancer, various methods are employed to determine clinical disease stage. Peritoneal metastases are common in gastric cancer, but accurately detecting these peritoneal metastasis using conventional imaging techniques remains challenging. To increase the sensitivity of staging when gastric 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 fluid 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.
Objective:To assess the value of ctDNA detection using aneuploidy analyses of peritoneal lavage fluid using mFAST-SeqS method in a prospective cohort of patients with gastric cancer who undergo a staging laparoscopy, in addition to the current staging methods (cytology, radiology, laparoscopy) and blood ctDNA analysis.
- Conditions
- Gastric Cancer
- Being tested
- collection additional peritoneal lavage fluid
- Keywords
- peritoneal metastasis, cfDNA
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection additional peritoneal lavage fluidOther
collection additional peritoneal lavage fluid
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer patients | Operable patients who will undergo DLS for GC. Patients will be identified from the MDT (multidisciplinary tumor board). Receives: Other: collection additional peritoneal lavage fluid | |
| non-cancer controls | Patients who will undergo a planned laparoscopy for bariatric or gallbladder disease Receives: Other: collection additional peritoneal lavage fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity mFast-SeqS
The primary endpoint is the sensitivity of the mFast-SeqS technique in patients with GC, and refers to the ability of the mFast-SeqS technique to correctly identify patients with the pres-ence of tumor cells in the peritoneal cavity.
Measured: 4 years
Secondary outcomes (2)
DFS
No locoregional or distant recurrence of disease,
Measured: 2 years
Concordance detection rates peritoneal dissemination
- Concordance of detection rates of peritoneal dissemination will be analyzed using cohen's kappa/mcNemar's test
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start17 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Erasmus 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. B. (Bianca) Mostert, Erasmus Medical Center
- Investigators
- Bianca Mostert, MD, Principal investigator, Erasmus Medical CenterSjoerd Lagarde, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308510
- Sponsor's protocol ID
- MEC-2024 0533
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No