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New genetic panel could personalize cancer treatment

NCT ID NCT07555639

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study enrolls 4,000 people with breast, ovarian, or colorectal cancer to test a comprehensive genetic panel. The panel looks for inherited cancer risks and tumor mutations that may affect drug sensitivity. Researchers aim to validate these genetic findings to potentially guide more personalized treatment decisions in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Genomic profile (NGS gene panel)
What this could lead to
If successful, this could improve personalized cancer care by better matching treatments to a patient's genetic profile.
What could go wrong
This is an early feasibility study, not a treatment trial. It may not directly improve outcomes, and the panel's accuracy needs validation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4,000 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Ovary Newly diagnosed patients with epithelial ovarian, peritoneal, or fallopian tube tumors of any histology and stage, excluding borderline tumors, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample is required. Age \> 18 years. Written informed consent. Patients with recurrent disease, either untreated or treated with no more than one prior line of therapy, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy), provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible. Patients in remission (identified during follow-up) who have received no more than one prior line of therapy, provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years. Breast Triple-negative breast cancer (ER and PgR \<10% and HER2 negative: IHC 0, 1+, or 2+ with non-amplified ISH) or breast cancer diagnosed in patients younger than 40 years, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). Eligible patients include: Early-stage disease (neoadjuvant or adjuvant setting). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample before chemotherapy is required. Metastatic disease. In this setting, prior chemotherapy for early-stage breast cancer (neoadjuvant and/or adjuvant) is allowed, provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible. Patients in remission (identified during follow-up) who have received no more than one prior line of therapy (in any setting), provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years. Age \> 18 years. Written informed consent. Colorectal Newly diagnosed patients with colorectal cancer (including metastatic disease) who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample is required. Age \> 18 and \< 50 years. Written informed consent. Patients with recurrent disease, either untreated or treated with no more than one prior line of therapy, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy), provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible. Patients in remission (identified during follow-up) who have received no more than one prior line of therapy, provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years. Exclusion Criteria: Inability or unwillingness to undergo oncogenetic counseling; More than one prior line of chemotherapy (in any disease setting); For patients enrolled in the absence of active disease and identified during follow-up, unavailability of untreated tumor tissue obtained within the previous 2 years; For patients enrolled with active disease, tumor site not accessible for biopsy sampling.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

    Roma, Roma, 00136, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.