NCT03604926

Brief Summary

Immune therapy represents a promising option for the treatment of an increasing number of malignancies. New immunotherapeutic strategies are currently under development and will be further studied starting from refractory settings of heavily pre-treated mCRC patients. On this basis, a specific immunological characterization of CRC metastasis will be relevant to direct future clinical and pharmacological research. As surgery is a therapeutic option in the treatment of mCRC, a percentage of mCRC patients undergo to resection of metastasis before or after medical treatment. These tumour samples could be useful to define the immune signature of colorectal metastatic disease. On the basis of the above reported considerations, an exploratory, prospective, observational study for the immunophenotypical characterization of colorectal cancer metastasis from pre-treated vs chemo-naive patients has been planned.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

October 5, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

February 28, 2018

Last Update Submit

November 19, 2020

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • immunological features of metastasis

    Tumor-infiltrating lymphocytes (TIL)

    through study completion, an average of 1 year

Study Arms (2)

chemo-naive patients

pre-treated patients with systemic chemotherapy +/- a targeted

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pre-treated or chemo-naive patients with resected CRC metastasis

You may qualify if:

  • Histological diagnosis of colorectal cancer
  • Metastatic disease
  • Surgery for metastatic disease
  • Availability of clinical data

You may not qualify if:

  • Non-metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

February 28, 2018

First Posted

July 30, 2018

Study Start

October 5, 2017

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

IT(1)