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Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up
The ct DNA R0 study is a prospective, open labelled, monocentric trial. The aim is to evaluate the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up.
The patient will have a blood sample before and after the surgery and during the post-surgery follow-up. The patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological/Vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | 7,5 ml of patient peripherical blood will be collected at each blood sample. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the circulating tumor DNA rate before/after surgery and the rate of effective complete resection | Comparison the circulating tumor DNA rate before/after surgery and the rate of effective complete resection. | Up to one month |
| Measure | Description | Time Frame |
|---|---|---|
| stability of the circulating tumor DNA on 2 pre-surgery samples | Comparison the circulating tumor DNA rate before/after surgery | Up to one month |
| Study of the correlation between the variation rate of the circulating tumor DNA at different points (T0, T1, T2, T3, T4 and Tn) and the apparition time of metastasis on hepatic MRI during the study follow-up. |
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Inclusion Criteria:
Aged 18 years old or more
Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).
No other distant metastasis (CT thoracic -abdomino -pelvic, bone scan).Measurable metastatic disease (echography, CT and/or MRI, FDG-PET, (fluoro- D-glucose integrated with computed tomography)).
Patient able to stand a blood collection.
Patient explanation given and consent information signed or by legal representative.
Exclusion Criteria:
Patient without social protection / insurance..
Patient with hepatic metastasis unresectable by surgery
Patient with extra-hepatic metastasis.
Person deprived of liberty or under guardianship
Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.
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| Name | Affiliation | Role |
|---|---|---|
| Pascale Mariani, MD | Institut Curie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36847256 | Result | Mariani P, Bidard FC, Rampanou A, Houy A, Servois V, Ramtohul T, Pierron G, Chevrier M, Renouf B, Lantz O, Gardrat S, Vincent-Salomon A, Roman-Roman S, Rodrigues M, Piperno-Neumann S, Cassoux N, Stern MH, Renault S. Circulating Tumor DNA as a Prognostic Factor in Patients With Resectable Hepatic Metastases of Uveal Melanoma. Ann Surg. 2023 Oct 1;278(4):e827-e834. doi: 10.1097/SLA.0000000000005822. Epub 2023 Feb 27. |
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Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Timepoints : T0 and T1 : before surgery T2 : 2 days after surgery T3 : 8 days after surgery T4 to T9 : every 4 months up to two years. |
| two years |
| Detection of GNA11 or GNAQ mutation on one of the hepatic metastasis | Search of GNA 11 or GNAQ mutation by Next Generation Sequencing techniques | Up to one month |
| Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis. | Up to one month |
| Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis) | Up to one month |
| Detection of genetic factors for uveal melanoma | Search of genetic factors for uveal melanoma to be used as predictive evidence of the clinical response for possible future treatment | Up to one month |
| Study of overall survival after HMUM resection | 5 years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |