NCT05051423

Brief Summary

The main aim was to assess the tumor vascular perfusion pattern in gastric cancer (GC). The investigators used dynamic contrast harmonic imaging endoscopic ultrasound (CHI-EUS) and the results were compared with the immunohistochemical expression of CD105 and clinico-pathological parameters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 21, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

September 10, 2021

Last Update Submit

September 24, 2021

Conditions

Gastric Cancer

Keywords

gastric cancerperfusion pattern in gastric cancerCHI-EUS

Outcome Measures

Primary Outcomes (1)

  • Correlations with statistical significance between time-intensity curve analysis parameters, immunohistochemical markers of angiogenesis and clinico-pathological parameters.

    The investigators expect to see correlations with statistical significance between immunohistochemical markers of angiogenesis (CD105), clinico-pathological and time-intensity curve (TIC) parameters :peak enhancement (PE), wash-in area under the curve (WiAUC), rise time (RT), mean transit time (mTTI), time to peak (TTP), wash-in rate (WiR), wash-in perfusion index (WiPI), wash-outAUC (WoAUC) and wash-in and wash-outAUC (WiWoAUC), fall time (FT), wash-out rate (WoR), quality of fit (QOF), region of interest area (ROI area).

    1 year

Study Arms (1)

Patients diagnosed with primary gastric tumors referred to our department for EUS local staging.

Patients will be included or excluded according to the following criteria used throughout the study: * Inclusion criteria: Patients diagnosed with primary gastric tumors referred for local staging by EUS (n=40); Age 18 to 90 years old, men or women; Signed informed consent for EUS with contrast-enhancement and tissue sampling * Exclusion criteria: Prior treatment with chemo-radiotherapy; Failure to provide informed consent; severe coagulopathy. Data collected for each participant will include: Personal data (name, surname, age, sex); results from previous investigations (blood count, liver and renal function tests, tumoral markers, gastroscopy, computed tomography), EUS variables (including CEH-EUS), histological and immunohistochemical findings, TNM and pTNM status (if possible), molecular analysis findings.

Diagnostic Test: Endoscopic ultrasound

Interventions

Endoscopic ultrasoundDIAGNOSTIC_TEST

Imaging tests: All patients will be evaluated by EUS and CEH-EUS, using radial EUS instruments. Prior to the investigation the stomach has to be empty for at least 8 hours. During the examination biopsies will be taken from normal and tumor tissue for gene expression analysis. CEH-EUS procedure: A two panel image with the usual conventional gray-scale B-mode EUS image on the right side and with the contrast harmonic image on the left side will be used, according to pre-established presets. The starting point of the timer will be considered the moment of intravenous contrast injection (Sonovue 2,4 mL), with the whole movie (T0-T120s) recorded on the embedded HDD of the ultrasound system for later analysis Molecular tests: Blood analysis. Whole blood (1ml) will be collected before imaging procedures in an Eppendorf tube on EDTA solution. Biopsy samples of normal and GC tissue. Gene expression will be analyzed using qPCR with Taqman®- labeled probes.

Also known as: Upper endoscopy, Blood sampling
Patients diagnosed with primary gastric tumors referred to our department for EUS local staging.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with primary gastric tumors referred for local staging by EUS; Age 18 to 90 years old, men or women;

You may qualify if:

  • patients diagnosed with primary gastric adenocarcinoma;
  • no neoadjuvant therapy;
  • age: 18 to 90 years old;
  • gender: men or women;
  • signed informed consent for EUS with contrast-enhancement and tissue sampling;

You may not qualify if:

  • other types of gastric cancer than adenocarcinoma;
  • prior treatment with chemo-radiotherapy;
  • failure to provide informed consent;
  • severe coagulopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy

Craiova, Romania

RECRUITING

Related Publications (10)

  • Folkman J. Fundamental concepts of the angiogenic process. Curr Mol Med. 2003 Nov;3(7):643-51. doi: 10.2174/1566524033479465.

    PMID: 14601638BACKGROUND

  • Kerbel RS. Tumor angiogenesis. N Engl J Med. 2008 May 8;358(19):2039-49. doi: 10.1056/NEJMra0706596. No abstract available.

    PMID: 18463380BACKGROUND

  • Shibuya M, Claesson-Welsh L. Signal transduction by VEGF receptors in regulation of angiogenesis and lymphangiogenesis. Exp Cell Res. 2006 Mar 10;312(5):549-60. doi: 10.1016/j.yexcr.2005.11.012. Epub 2005 Dec 5.

    PMID: 16336962BACKGROUND

  • Smith NR, Baker D, James NH, Ratcliffe K, Jenkins M, Ashton SE, Sproat G, Swann R, Gray N, Ryan A, Jurgensmeier JM, Womack C. Vascular endothelial growth factor receptors VEGFR-2 and VEGFR-3 are localized primarily to the vasculature in human primary solid cancers. Clin Cancer Res. 2010 Jul 15;16(14):3548-61. doi: 10.1158/1078-0432.CCR-09-2797. Epub 2010 Jul 6.

    PMID: 20606037BACKGROUND

  • Li L, Wang L, Song P, Geng X, Liang X, Zhou M, Wang Y, Chen C, Jia J, Zeng J. Critical role of histone demethylase RBP2 in human gastric cancer angiogenesis. Mol Cancer. 2014 Apr 9;13:81. doi: 10.1186/1476-4598-13-81.

    PMID: 24716659BACKGROUND

  • Ferrara N. Vascular endothelial growth factor. Eur J Cancer. 1996 Dec;32A(14):2413-22. doi: 10.1016/s0959-8049(96)00387-5. No abstract available.

    PMID: 9059329BACKGROUND

  • Ulyatt C, Walker J, Ponnambalam S. Hypoxia differentially regulates VEGFR1 and VEGFR2 levels and alters intracellular signaling and cell migration in endothelial cells. Biochem Biophys Res Commun. 2011 Jan 21;404(3):774-9. doi: 10.1016/j.bbrc.2010.12.057. Epub 2010 Dec 17.

    PMID: 21168388BACKGROUND

  • Chen CN, Hsieh FJ, Cheng YM, Cheng WF, Su YN, Chang KJ, Lee PH. The significance of placenta growth factor in angiogenesis and clinical outcome of human gastric cancer. Cancer Lett. 2004 Sep 15;213(1):73-82. doi: 10.1016/j.canlet.2004.05.020.

    PMID: 15312686BACKGROUND

  • Kondo K, Kaneko T, Baba M, Konno H. VEGF-C and VEGF-A synergistically enhance lymph node metastasis of gastric cancer. Biol Pharm Bull. 2007 Apr;30(4):633-7. doi: 10.1248/bpb.30.633.

    PMID: 17409493BACKGROUND

  • Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, Dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014 Jan 4;383(9911):31-39. doi: 10.1016/S0140-6736(13)61719-5. Epub 2013 Oct 3.

    PMID: 24094768BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples; biopsy samples of normal and gastric cancer tissue;

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

EndosonographyGastroscopyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresSpecimen HandlingClinical Laboratory TechniquesPuncturesInvestigative Techniques

Central Study Contacts

Adrian Saftoiu, Professor

CONTACT

+40 744 823355adriansaftoiu@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2021

First Posted

September 21, 2021

Study Start

November 1, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)