Splenic Hilar Nodes in Splenic Flexure Cancer | NCT04666883

Studies
Splenic Hilar Nodes in Splenic Flexure Cancer

NCT04666883

Sponsor

University of Rome Tor Vergata

Status

Unknown status

Last Update Posted

Dec 29, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Colon Cancer
Metastases, Lymphatic

Interventions

Review of records and follow up

Countries

Italy

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

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Estimated

Primary Completion Date

Mar 1, 2021Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Dec 8, 2020

First Submission Date that Met QC Criteria

Dec 8, 2020

First Posted Date

Dec 14, 2020Actual

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

Dec 24, 2020

Last Update Posted Date

Dec 29, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Sigismondo Sica, Associate Professor, Head of Department, University of Rome Tor VergataPrincipal Investigator

Lead Sponsor

University of Rome Tor VergataOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Splenic flexure cancer patients		Splenic flexure cancer patients	Other: Review of records and follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Review of records and follow up	Other	Follow up to identify patients who developed splenic hilar nodal metastases	Splenic flexure cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Splenic hilum nodal metastases	Splenic hilum nodal metastases	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All splenic flexure cancer patients

Exclusion Criteria:

No consent to data utilization

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

Patients with cancer of the splenic flexure of the colon

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bruno Sensi, MD	Contact	3385352902		brunosensi@outlook.it
Giuseppe S Sica, MD, PhD	Contact	3385333659		sigisica@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Tor Vergata		Roma	RM	00133	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D008207	Lymphatic Metastasis

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided