OncologyPIPONCT07593053
Phase I Prognostic Online (PIPO) Tool
An observational study of Oncology, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Immune checkpoint inhibitor, targeted agents
- How many people
- 586 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2023to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Phase 1 patients that will receive IT or targeted agents
Who may be able to join
- Participants must have been enrolled in a VHIO phase 1 clinical trial or phase 2 basket trial included in this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Prognostic Online (PIPO) Tool: a New Aid to Improve Patient Selection for Early Phase Clinical Trials
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.
Read more
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.
Read the detailed description
Patient selection in phase I clinical trials continues to be a challenge even in the new "era" with immune checkpoints inhibitors (ICIs) and combinations with small molecules or targeted agents (TAs). Phase 1 trialists are more frequently dealing with novel compounds and new trial designs with large expansion cohort, looking for preliminary evidence of anti-tumor activity and safety in different tumor types and disease settings. During these last years, certain phase 1 trials have had registrational value transforming the classical drug development path. Despite these trends, patients recruited in phase 1 trials are mostly refractory to standard-of-care therapies, where quality of life and life expectancy remain a cornerstone for trial selection. The need to balance potential risks of toxicity and benefits of investigational drugs in this particularly vulnerable cancer population is critical. Most phase 1 clinical trials use life expectancy of at least 3 months as a specific inclusion criterion to minimize the chances of clinical deterioration during the dose limiting toxicity (DLT) assessment period. Nevertheless, there is no consensus on how to objectively make this estimation in real practice.
Several prognostic scores have been developed for phase 1 trials. Most are based on overall survival (OS) prediction but not in the specific timepoint of survival rate at 3 months (3m). These scores were developed for patients treated with cytotoxic agents or targeted drugs in phase 1 units of the Royal Marsden Hospital (RMH score) and the MD Anderson Cancer Center (MDACC). Additionally, prognostic scores specifically for ICIs have been designed at Gustave Roussy Hospital, Paris, France, (GRIm-Score) or MDACC (MDA-ICI) while the Lung Immune Prognostic Index (LIPI) score has been validated as a prognostic score not only for ICIs, but also chemotherapy and TAs.
Most recently, the investigators proposed the Phase I prognostic online (PIPO) tool that was developed interchangeably for TAs and ICIs. The PIPO tool avoid dichotomization of continuous or ordinary variables and provide estimation of specific survival probabilities for each patient before enrolment in a phase 1 trial. To better validate the tool, the investigators plan a prospective validation to assess its prognostic capacity in order to be used as a decision support system in clinical practice of drug development units for objectively estimating life expectancy criterion in phase 1 trials.
- Conditions
- Oncology
- Being tested
- Immune checkpoint inhibitor, targeted agents
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune checkpoint inhibitor, targeted agentsDrug
Immune checkpoint inhibitor, targeted agents
| Study group | Role | What they receive |
|---|---|---|
| Patients candidates for Phase 1 trials | Not described Receives: Drug: Immune checkpoint inhibitor, targeted agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
overall survival as a continuous variable and 3 months overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start2 Feb 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vall d'Hebron Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593053
- Sponsor's protocol ID
- PR(AG)675/2020
- Acronym
- PIPO
- Status last verified
- Mar 2023
- First submitted
- 11 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Prognostic Online (PIPO) Tool: a New Aid to Improve Patient Selection for Early Phase Clinical Trials
- ClinicalTrials.gov ID
- NCT07593053
- Acronym / sponsor ID
- PIPO / PR(AG)675/2020
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Vall d'Hebron Institute of OncologyUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient selection in phase I clinical trials continues to be a challenge even in the new "era" with immune checkpoints inhibitors (ICIs) and combinations with small molecules or targeted agents (TAs). Phase 1 trialists are more frequently dealing with novel compounds and new trial designs with large expansion cohort, looking for preliminary evidence of anti-tumor activity and safety in different tumor types and disease settings. During these last years, certain phase 1 trials have had registrational value transforming the classical drug development path. Despite these trends, patients recruited in phase 1 trials are mostly refractory to standard-of-care therapies, where quality of life and life expectancy remain a cornerstone for trial selection. The need to balance potential risks of toxicity and benefits of investigational drugs in this particularly vulnerable cancer population is critical. Most phase 1 clinical trials use life expectancy of at least 3 months as a specific inclusion criterion to minimize the chances of clinical deterioration during the dose limiting toxicity (DLT) assessment period. Nevertheless, there is no consensus on how to objectively make this estimation in real practice.
Several prognostic scores have been developed for phase 1 trials. Most are based on overall survival (OS) prediction but not in the specific timepoint of survival rate at 3 months (3m). These scores were developed for patients treated with cytotoxic agents or targeted drugs in phase 1 units of the Royal Marsden Hospital (RMH score) and the MD Anderson Cancer Center (MDACC). Additionally, prognostic scores specifically for ICIs have been designed at Gustave Roussy Hospital, Paris, France, (GRIm-Score) or MDACC (MDA-ICI) while the Lung Immune Prognostic Index (LIPI) score has been validated as a prognostic score not only for ICIs, but also chemotherapy and TAs.
Most recently, the investigators proposed the Phase I prognostic online (PIPO) tool that was developed interchangeably for TAs and ICIs. The PIPO tool avoid dichotomization of continuous or ordinary variables and provide estimation of specific survival probabilities for each patient before enrolment in a phase 1 trial. To better validate the tool, the investigators plan a prospective validation to assess its prognostic capacity in order to be used as a decision support system in clinical practice of drug development units for objectively estimating life expectancy criterion in phase 1 trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients candidates for Phase 1 trials | – | Drug: Immune checkpoint inhibitor, targeted agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1 patients that will receive IT or targeted agents
Key inclusion criteria (1 listed)
- Participants must have been enrolled in a VHIO phase 1 clinical trial or phase 2 basket trial included in this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune checkpoint inhibitor, targeted agentsImmune checkpoint inhibitor, targeted agents | Drug | Patients candidates for Phase 1 trials |
Primary outcome
Overall survival
Time frame: 1 year
overall survival as a continuous variable and 3 months overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Vall d'Hebron Institute of Oncology at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.