Multicenter Cohort Prospective Study on Multidisciplinary... | NCT01651026

Studies
Multicenter Cohort Prospective Study on Multidisciplinary Treatment of Rectal Cancer

NCT01651026

Sponsor

National Cancer Institute, Naples

Status

Unknown status

Last Update Posted

Mar 24, 2023Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Metastatic Colorectal Cancer

Interventions

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Jul 24, 2012

First Submission Date that Met QC Criteria

Jul 25, 2012

First Posted Date

Jul 26, 2012Estimated

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 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to describe the diagnostic and treatment procedures employed for patients with rectal cancer in each participating center. Outcomes to treatment, costs of treatment will be described. Exploratory analyses will be done to identify factor that influence patient prognosis, as well as factors that predict patient response to treatment.

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

Not provided

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

600Estimated

Label	Type	Description	Intervention Names
rectal cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
list of diagnostic procedures used in clinical practice, according to participating Institute		5 years

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
all treatments received for colorectal cancer (surgery, radiation therapy, chemotherapy, supportive care, etc) per patient		5 years
rectal cancer surgical interventions/approaches per participating center		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic diagnosis rectal carcinoma
Signed informed consent

Exclusion Criteria:

Refusal or incapability of providing informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive patients at participating Institutes with confirmed diagnosis of colorectal cancer.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Perrone, M.D., Ph.D.	Contact	+39 081 5903571		francesco.perrone@usc-intnapoli.net
Marilina Piccirillo, M.D.	Contact	+39 081 5903383		marilina.piccirillo@usc-intnapoli.net

Overall Officials

Name	Affiliation	Role
G. Romano, M.D.	National Cancer Institute, Naples	Principal Investigator
C. Sassaroli, M.D.	National Cancer Institute, Naples	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
A.O.R.N. V. Monaldi	Recruiting	Naples			Italy
A.O.U. Federico II

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided