NCT04455282

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2021Jan 2028

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Expected
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

3.9 years

First QC Date

June 29, 2020

Last Update Submit

March 7, 2024

Conditions

Cancer of EsophagusEsophagogastric Junction Disorder

Keywords

Circulating BiomarkersCTCtdEVsctDNA

Outcome Measures

Primary Outcomes (1)

  • Difference in CTC detection rate between peripheral and tumor draining veins.

    The difference between the CTC positivity rate (≥1 CTC / 7.5 mL) in blood samples of tumor-draining veins compared to the CTC positivity rate in peripheral blood. The positivity fraction and CTC number per 7.5 mL in tumor draining veins and peripheral blood samples will be determined by CellSearch.

    24 months

Secondary Outcomes (4)

  • tdEVs

    24 months

  • ctDNA

    24 months

  • Clinical correlation

    84 months

  • Dynamic Biobank

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The targeted study population of CIRCULATE1 are 100 patients (see 2.3) with resectable GEAC (GEJ type I-II) undergoing surgery with curative intention. The patients will be recruited and screened consecutively by trained surgeons involved into the CIRCULATE study. Patients are recruited to participate in this study at the outpatient clinic

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

RECRUITING

Universitätsklinikum Münster

Münster, North-Rhine Westfalia, 48149, Germany

NOT YET RECRUITING

Related Publications (5)

  • de Wit S, Rossi E, Weber S, Tamminga M, Manicone M, Swennenhuis JF, Groothuis-Oudshoorn CGM, Vidotto R, Facchinetti A, Zeune LL, Schuuring E, Zamarchi R, Hiltermann TJN, Speicher MR, Heitzer E, Terstappen LWMM, Groen HJM. Single tube liquid biopsy for advanced non-small cell lung cancer. Int J Cancer. 2019 Jun 15;144(12):3127-3137. doi: 10.1002/ijc.32056. Epub 2019 Jan 28.

    PMID: 30536653BACKGROUND

  • Belic J, Koch M, Ulz P, Auer M, Gerhalter T, Mohan S, Fischereder K, Petru E, Bauernhofer T, Geigl JB, Speicher MR, Heitzer E. Rapid Identification of Plasma DNA Samples with Increased ctDNA Levels by a Modified FAST-SeqS Approach. Clin Chem. 2015 Jun;61(6):838-49. doi: 10.1373/clinchem.2014.234286. Epub 2015 Apr 20.

    PMID: 25896989BACKGROUND

  • Reeh M, Effenberger KE, Koenig AM, Riethdorf S, Eichstadt D, Vettorazzi E, Uzunoglu FG, Vashist YK, Izbicki JR, Pantel K, Bockhorn M. Circulating Tumor Cells as a Biomarker for Preoperative Prognostic Staging in Patients With Esophageal Cancer. Ann Surg. 2015 Jun;261(6):1124-30. doi: 10.1097/SLA.0000000000001130.

    PMID: 25607767BACKGROUND

  • Pernot S, Badoual C, Terme M, Castan F, Cazes A, Bouche O, Bennouna J, Francois E, Ghiringhelli F, De La Fouchardiere C, Samalin E, Bachet JB, Borg C, Ducreux M, Marcheteau E, Stanbury T, Gourgou S, Malka D, Taieb J. Dynamic evaluation of circulating tumour cells in patients with advanced gastric and oesogastric junction adenocarcinoma: Prognostic value and early assessment of therapeutic effects. Eur J Cancer. 2017 Jul;79:15-22. doi: 10.1016/j.ejca.2017.03.036. Epub 2017 Apr 26.

    PMID: 28456090BACKGROUND

  • Buscail E, Chiche L, Laurent C, Vendrely V, Denost Q, Denis J, Thumerel M, Lacorte JM, Bedel A, Moreau-Gaudry F, Dabernat S, Alix-Panabieres C. Tumor-proximal liquid biopsy to improve diagnostic and prognostic performances of circulating tumor cells. Mol Oncol. 2019 Sep;13(9):1811-1826. doi: 10.1002/1878-0261.12534. Epub 2019 Jul 25.

    PMID: 31216108BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood, tumor material

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Nikolas Stoecklein, MD

    Surgery, University Hospital Düsseldorf Germany

    PRINCIPAL INVESTIGATOR

  • Christiane Bruns, MD

    Surgery, University Hospital Cologne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolas H Stoecklein, MD

CONTACT

004921181Nikolas.Stoecklein@med.uni-duesseldorf.de

Christiane Bruns, MD

CONTACT

christiane.bruns@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Experimental Surgical Oncology

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 2, 2020

Study Start

February 1, 2021

Primary Completion

December 30, 2024

Study Completion (Estimated)

January 30, 2028

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

DE(2)