EUS Guided HVA and PVA for Circulating Tumor DNA in Patients | NCT04782557

Studies
EUS Guided HVA and PVA for Circulating Tumor DNA in Patients

NCT04782557

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Mar 4, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Circulating Tumor Cell
Gastrointestinal Cancer

Interventions

EUS-guided portal vein and hepatic vein aspiration

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jan 5, 2021

First Submission Date that Met QC Criteria

Mar 1, 2021

First Posted Date

Mar 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2021

Last Update Posted Date

Mar 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The discovery of cell-free circulating tumor DNA (crDNA) in blood and the maturation of technologies for ctDNA analysis have presented an attractive opportunity for minimally invasive "liquid biopsy" genomic diagnostics. The investigators plan to perform EUS-guided portal vein and hepatic vein aspiration in GI cancers patients. The aim of the current study is thus to examine the concentration of ctDNA in portal vein (EUS-guided PVA), hepatic vein (EUS-guided HVA) and peripheral blood to understand the first pass effect of the liver with gastrointestinal (GI) cancers, and the possibility of using ctDNA as a marker for preoperative staging, restaging after neoadjuvant chemotherapy, and monitoring for recurrence.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUS-guided PVA and HVA	Experimental	Patient will undergo EUS-guided PVA and HVA	Diagnostic Test: EUS-guided portal vein and hepatic vein aspiration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUS-guided portal vein and hepatic vein aspiration	Diagnostic Test	EUS-guided portal vein and hepatic vein aspiration	EUS-guided PVA and HVA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Variant allelic fraction (expressed in %) of serum ctDNA from HVB, PVB and peripheral blood	Plasma DNA will be extracted using the QIAamp Circulating Nucleic Acid Kit (Qiagen), and the concentration of the circulating tumor DNA will be reported in variant allelic fraction (expressed in %)	3 months

Secondary Outcomes

Measure	Description	Time Frame
Variant allelic fraction (expressed in %) of Genomic and proteomic analysis of ctDNA	If ctDNA is identified, further genomic and proteomic analysis will be performed. It will be measured in terms variant allelic fraction (expressed in %)	3 months
Staging of the GI cancer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age >= 18 years old
Newly diagnosed stage II-IV distal gastric cancer, pancreatic cancer or colorectal cancer
Undergoing treatment with either:
1. Surgery
2. Neoadjuvant chemotherapy
3. Neoadjuvant chemoirradiation
4. Palliative chemotherapy/ immunotherapy
  
  Exclusion criteria:
1. Synchronous cancer of other sites
2. Cardia, high lesser curve tumors, oesophagogastric junction tumors
3. Presence of bulky lymph nodes at lesser curve/ coeliac region precluding a clear EUS puncture site to portal vein and hepatic vein
4. Patients with coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
5. Patients unwilling to undergo follow-up assessments
6. Patients with liver cirrhosis, portal hypertension and/ or gastric varices
7. Patient refusal to participate
  
  -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009360	Neoplastic Cells, Circulating
D005770	Gastrointestinal Neoplasms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes