CIRCULATing Biomarkers for Individualized Surgical Therapy in gastroEsophageal Cancer - Phase 1

Launched by HEINRICH-HEINE UNIVERSITY, DUESSELDORF · Jun 29, 2020

Keywords

ClinConnect Summary

The CIRCULATE trial is studying how certain blood markers can help doctors better understand and treat patients with a specific type of esophageal cancer known as adenocarcinoma. The trial aims to find out if analyzing these markers, particularly from blood taken from both the tumor and other veins, can improve the way doctors stage the cancer and identify patients who might be at a higher risk of the cancer spreading. This information could help tailor treatments for patients, ranging from more intensive therapy to surgery alone, enhancing their chances for a successful outcome.

To participate, patients must be at least 18 years old and have a confirmed diagnosis of resectable (removable) adenocarcinoma of the gastro-esophageal junction, with no signs of metastasis (spread to other parts of the body). During the study, participants will provide blood samples before surgery and additional samples during follow-ups over five years. This trial is currently recruiting participants, and it’s important for anyone considering joining to understand what’s involved and to provide informed consent.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • tumors of squamous, adenosquamous or other non-adenocarcinoma histology
• • 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
• • unsigned informed consent