NCT07593053

Brief Summary

Clinical trials are studies that test new treatments to see if they work and are safe for people with certain illnesses. Phase I clinical trials are the earliest stage of testing, where researchers give a new treatment to a small group of people to see if it's safe and how much of it can be given before causing harmful side effects. Selecting patients for these trials is challenging, especially since most of them have already tried other treatments that didn't work. To make sure patients are not harmed during the trial, researchers need to estimate how long they might live, so they don't give the new treatment to someone who might not live long enough to see if it works. Doctors use a variety of tools to estimate how long a patient might live, but it's not always easy to do. To help with this, researchers have developed a new tool called the Phase I prognostic online (PIPO) tool. It helps estimate how long a patient might live by looking at different factors like age, the type of cancer, and other medical conditions. This tool can help doctors decide if a patient should be included in a clinical trial or not. The researchers plan to test this tool to see how well it works, with the goal of using it in clinical practice to help doctors estimate life expectancy and select patients for clinical trials. This will make it easier for doctors to help their patients get access to new treatments that might help them.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
586

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

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

February 2, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 22, 2026

Status Verified

March 1, 2023

Enrollment Period

3.2 years

First QC Date

May 11, 2026

Last Update Submit

May 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    overall survival as a continuous variable and 3 months overall survival

    1 year

Study Arms (1)

Patients candidates for Phase 1 trials

Drug: Immune checkpoint inhibitor, targeted agents

Interventions

Immune checkpoint inhibitor, targeted agents

Patients candidates for Phase 1 trials

Eligibility Criteria

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

Phase 1 patients that will receive IT or targeted agents

You may qualify if:

  • \- Participants must have been enrolled in a VHIO phase 1 clinical trial or phase 2 basket trial included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron Institue of Oncology

Barcelona, Spain

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Study Design

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

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 18, 2026

Study Start

February 2, 2023

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

May 22, 2026

Record last verified: 2023-03

Locations