NCT01651026

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.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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

January 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2012

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

13.9 years

First QC Date

July 24, 2012

Last Update Submit

March 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • list of diagnostic procedures used in clinical practice, according to participating Institute

    5 years

Other Outcomes (6)

  • 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

  • disease outcomes per patient per treatment received

    5 years

  • +3 more other outcomes

Study Arms (1)

rectal cancer

Eligibility Criteria

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

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

You may qualify if:

  • Histologic diagnosis rectal carcinoma
  • Signed informed consent

You may not qualify if:

  • Refusal or incapability of providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

A.O.R.N. V. Monaldi

Napoli, Italy

RECRUITING

A.O.U. Federico II

Napoli, Italy

RECRUITING

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • G. Romano, M.D.

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR
  • C. Sassaroli, M.D.

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR
  • M. C. Piccirillo, M.D.

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR
  • Francesco Perrone, M.D., Ph.D

    National Cancer Institute, Naples

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Perrone, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 26, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations