Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (ct DNA R0)

Uveal Melanoma Clinical Trial

Official title:

Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849145
• Other study ID #: IC 2014-06 ctDNA R0
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: February 25, 2020

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 years old or more

2. Patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (R0).

3. 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)).

4. Patient able to stand a blood collection.

5. Patient explanation given and consent information signed or by legal representative.

Exclusion Criteria:

6. Patient without social protection / insurance..

7. Patient with hepatic metastasis unresectable by surgery

8. Patient with extra-hepatic metastasis.

9. Person deprived of liberty or under guardianship

10. Inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Biological:
• Blood sampling
7,5 ml of patient peripherical blood will be collected at each blood sample.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	stability of the circulating tumor DNA on 2 pre-surgery samples	Comparison the circulating tumor DNA rate before/after surgery	Up to one month
Secondary	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.	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
Secondary	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
Secondary	Comparative study of the mutation profile of the ocular tumor if available, resected hepatic metastasis.		Up to one month
Secondary	Histological study of the resected hepatic metastasis (inflammation, Ki 67, necrosis, fibrosis and vascularization, genomic analysis of the metastasis)		Up to one month
Secondary	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
Secondary	Study of overall survival after HMUM resection		5 years