Detection of Aneuploidy in Cell Free DNA to Improve the Sensitivity of Diagnostic Peritoneal Lavage in Gastric Cancer

NCT06308510 | Recruiting

• 1 other identifier: MEC-2024 0533
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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 evaluation method in GC patients.

Conditions

Gastric Cancer

Keywords

peritoneal metastasis; cfDNA

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (2)

• DFS

  2 years

• Concordance detection rates peritoneal dissemination

  4 years

Study Arms (2)

Gastric cancer patients

Operable patients who will undergo DLS for GC. Patients will be identified from the MDT (multidisciplinary tumor board).

Other: collection additional peritoneal lavage fluid

non-cancer controls

Patients who will undergo a planned laparoscopy for bariatric or gallbladder disease

Other: collection additional peritoneal lavage fluid

Interventions

collection additional peritoneal lavage fluid OTHER

collection additional peritoneal lavage fluid

Gastric cancer patients; non-cancer controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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);

You may qualify if:

• Age ≥18 years old;
• Written informed consent according to the ICH-GCP and national/local regula-tions.

You may not qualify if:

• \- Language difficulty, dementia or altered mental status prohibiting the under-standing and giving of informed consent.
• non-cancer controls:
• 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.
• 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).

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015GD, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peritoneal lavage fluid, which may contain cfDNA in non-cancer controls and gastric cancer patients, and blood in gastric cancer patients

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Bianca Mostert, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Sjoerd Lagarde, MD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessie Huizer, Drs.

CONTACT

+31107034523; t.j.huizer@erasmusmc.nl

Niels Guchelaar

CONTACT

n.guchelaar@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)