Prediction of True Oligo-metastatic Disease. (PREDICTION)

April 7, 2023 updated by: National Cancer Institute, Naples

Oligo-metastatic neoPlasms From the gastRo-intEstinal Tract: iDentIfiCaTIon Of cliNical and Molecular Drivers: the PREDICTION Study

In recent years, the scientific community has recognized the need to differentiate between poly- and oligo-metastatic disease (OMD) in oncology due to their distinct clinical and biological behavior. The definition of "true" and good-prognosis OMD is necessarily retrospective, as many patients initially considered oligo-metastatic develop poly-metastatic disease within one year. The PREDICTION study is a prospective, observational, and monocentric investigation. The study has two primary objectives. The first one is descriptive and aims to determine the prevalence of specific biological characteristics in OMD derived from gastrointestinal tract neoplasms (colon, stomach, biliary tract, exocrine glands of the digestive tract). These biological characteristics include genetic landscape and T lymphocyte infiltrate of the primary tumor and/or metastases. Genetic assessment will be done on formalin-fixed paraffin-embedded (FFPE) tissues or liquid biopsies with the Oncomine Solid Tumour DNA kit (Thermo Fisher Scientific, Waltham, MA, USA). Data analysis will be performed using the Torrent Suite Software v5.0 (Thermo Fisher Scientific). The analysis of T lymphocytes will be conducted through immunohistochemistry (IHC) in primary and or metastatic tissues (if available). The second co-primary objective aims to identify OMD through the prognostic effect of a score designed ad hoc. It is tested in a single pathology, namely in patients with metastatic colorectal cancer. A score is constructed based on the following characteristics, with possession of all characteristics (3+) constituting the full score: a primitive/metastasis genetic concordance >80% = 1 point; high T-lymphocyte infiltration GRZB+ (>10 cells/mm2) in the primary tumor and/or metastases (where tissue is available) = 1 point; absence of clonal evolution favoring specific key-driver genes = 1 point. The hypothesis is that patients with true OMD (score 3+) have a significantly lower rate of progression at one year, defined as recurrence after radical surgery or progression (in oligometastatic patients who are not candidates for upfront definitive local treatment) based on RECIST v 1.1 criteria since enrollment in the study, compared to those with false OMD who subsequently develop polymetastatic disease. The treatments will be chosen at the discretion of the referring Oncologist, in multidisciplinary sessions, according to normal clinical practice. The sample size was determined using a two-sided test of difference between proportions to evaluate the statistical significance of the difference in recurrence within 1 year. For this purpose, the following scenario was considered: a reasonable probability of the simultaneous occurrence of the 3 factors in true OMD (score 3+) of 60%; a recurrence rate of 20% for true OMD (score 3+), and 80% for false OMD (score <3+). With a significance level of α=0.05, a test power of 90%, and a Fisher exact test, the required number of patients to be enrolled is 32, to be recruited over an expected period of 2 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients affected by gastroenteric tumors (colon, stomach, biliary tract, exocrine glands of the digestive tract) with oligo-metastatic disease. Oligometastatic patients will be defined as those presenting with one to three lesions per organ with a maximum tumor diameter of less than 70 mm and no lesion with a diameter greater than 25 mm.

Description

Inclusion Criteria:

  • Patients eligible for inclusion in this study must meet the following criteria:
  • Diagnosis of gastroenteric tumors (colon, stomach, biliary tract, exocrine glands of the digestive tract);
  • OMD: one to three lesions per organ with a maximum tumor diameter of less than 70 mm and no lesion with a diameter greater than 25 mm;
  • Availability of FFPE (Formalin Fixed Paraffin Embedded) inclusions from resected primary tumor;
  • Written informed consent.

Exclusion Criteria:

  • Previous or concurrent malignant neoplasms;
  • Presence of cerebral metastases;
  • Refusal or inability to provide informed consent;
  • Inability to guarantee follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression/Recurrence
Time Frame: 1 year
Rate of recurrence/progression within one year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCINaples

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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