NCT04455282Recruiting
CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1
Source: ClinicalTrials.gov · Last updated 8 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is an exploratory observational biomarker study in approximately 100 eligible patients with resectable adenocarcinomas of the esophagus and gastro- esophageal junction (GEJ) type I-II (GEAC) to investigate the difference deletion frequency of circulating tumor cells (CTCs) between peripheral veins and tumor-draining veins (primary endpoint), prognostic value, relevance of a set of two additional blood-based biomarkers analyzed from a single blood sampling tube (secondary endpoints). The underlying hypothesis is that the biomarker alone or in combination improve preoperative staging and help to identify patients at risk for metastasis. This should enable a better stratification of GEAC patients to neo-adjuvant treatment, (intensified) peri-operative treatment, or even surgery alone, in selected cases. The data of the CIRCULATE study shall be used design subsequent studies testing the predictive role of these biomarkers for surgical management. Patients will provide blood samples and lymphatic fluid during the operation and annual blood samples during clinical follow up of 5 years.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 29 Jun 2020
- Start date
- 1 Feb 2021
- Primary completion date
- 30 Dec 2024
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04455282
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Feb 2021 to the primary completion date, 30 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with inoperable or metastatic GEJ type I and II adenocarcinoma, GEJ type I and II adenocarcinoma staged cT1N0 and cT4b, GEJ type I and II cT4a evaluated as not curatively resectable by the local surgical investigator
Other
- tumors of squamous, adenosquamous or other non-adenocarcinoma histology
- unsigned informed consent
Who the study is looking for
- histologically proven adenocarcinoma of the GEJ type I and II, resectable, non-metastatic tumor
- age ≥18
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2,
- American Society of Anesthesiologists (ASA) \< 4.
- pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 GEJ type I and II adenocarcinomas can be included. In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior inclusion.
- Written informed consent and the ability to understand the nature of the study and the study-related procedures and to comply with them has to be ensured.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.