Multicenter Cohort Prospective Study on Multidisciplinary Treatment of Rectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— CROSS-1  

Official title:

Multicentered Observational Prospective Cohort Study on Multidisciplinary Treatment of Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01651026
• Other study ID #: CROSS-1
• Status: Recruiting
• Start date: January 2011
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: Francesco Perrone, M.D., Ph.D.
• Phone: +39 081 5903571
• Email: francesco.perrone[@]usc-intnapoli.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic diagnosis rectal carcinoma

• Signed informed consent

Exclusion Criteria:

• Refusal or incapability of providing informed consent

Related Conditions & MeSH terms

• Metastatic Colorectal Cancer
• Rectal Neoplasms

Locations

Country	Name	City	State
Italy	A.O.R.N. V. Monaldi	Napoli
Italy	A.O.U. Federico II	Napoli
Italy	Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	all treatments received for colorectal cancer (surgery, radiation therapy, chemotherapy, supportive care, etc) per patient		5 years
Other	rectal cancer surgical interventions/approaches per participating center		5 years
Other	disease outcomes per patient per treatment received		5 years
Other	estimated costs per treatment pattern per center		5 years
Other	factors that influence patient prognosis	exploratory analyses	5 years
Other	predictive factors for response to treatment	exploratory analyses	5 years
Primary	list of diagnostic procedures used in clinical practice, according to participating Institute		5 years