Tissue analysis may guide personalized cancer therapy
NCT ID NCT01856296
First seen Aug 10, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests whether analyzing a patient's tumor alongside a sample of their normal tissue can help doctors select a more effective treatment for advanced cancer. The approach aims to provide a personalized therapy choice for every participant, even those without known genetic mutations. Researchers will compare how long the chosen treatment controls the cancer versus the previous treatment. The study involves adults with metastatic cancer who can safely undergo a biopsy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biopsy procedure for molecular analysis
- What this could lead to
- If successful, this approach could help doctors choose more effective, personalized treatments for people with advanced cancer, potentially improving survival.
- What could go wrong
- This is an early-stage exploratory study, and the benefit of this biopsy-guided approach is not yet proven. It may not work for all patients or cancer types, and biopsies carry risks like bleeding or infection.
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
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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
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303 people
The number who actually took part.
- Started
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Apr 2013
- Finished
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Feb 2019
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Informed consent * Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained. * Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on at least one prior regimen for advanced disease. * Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart. * Age from 18 years * Life expectancy of at least 3 months * ECOG Performance status of 0 to 1 * Measurable or evaluable disease according to RECIST 1.1 criteria * For U.S. sites, advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months. Exclusion Criteria: * Any patient that might require a lung or brain biopsy are excluded (at US sites) * Alteration of organ function or hematopoietic function as defined by the following criteria: 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \>2.5 x upper limit of normal (ULN), except for patients with liver metastases, for which AST and ALT \> 5.0 ULN is the exclusion criteria. 2. Bilirubin \> 2.0 ULN 3. Polynuclear neutrophil \< 1.5 x 109/L 4. Platelets \< 100 x 10 9/L 5. Hemoglobin \< 90 g/L 6. Creatinine \> 1.5 ULN 7. Calcemia \> 1.5 ULN 8. Phosphatemia \> 1.5 ULN * Coagulation abnormality prohibiting a biopsy * Symptomatic or progressive brain metastases detected by radio imaging, or meningeal * Patient who received a personalized therapeutic treatment based on molecular anomaly during the treatment period prior to the WINTHER directed treatment (defining the PFS1). Hormonal therapy may be continued during WINTHER suggested therapy. The exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are EMA approved and genomically matched to patients. If there are questions about whether or not a prior therapy is matched targeted treatment it will be agreed on by discussion between PIs who are also Clinical Management Committee members; the resolution should take place prior to starting WINTHER directed treatment.
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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
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Institut Gustave Roussy
Villejuif, Val de Marne, 94805, France
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