Circulating Melanoma Cells in Metastatic Patients Treated With Selective BRAF Inhibitors

NCT ID: NCT01878396

Last Updated: 2016-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this study, is to evaluate Circulating Melanoma Cell (CMC) changes in Metastatic Melanoma (MM) patients, undergoing treatment with selective inhibitors of mutated BRAF.

Detailed Description

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This is an observational prospective pilot study aimed to investigate the association between changes of total and apoptotic CMC count and disease progression in MM patients undergoing treatment with selective inhibitors of mutated B-RAF.

Conditions

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Metastatic Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mutated Anti-B-RAF

Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors.

Anti-B-RAF

Intervention Type DRUG

Interventions

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Anti-B-RAF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fourth stage Melanoma patients with both measurable and not measurable lesions undergoing treatment with selective B-RAF inhibitors will be included. To determine the prevalence of CMC-positive patients in IV stage Melanoma, patients without mutated B-RAF undergoing chemotherapy and/or vaccines will be also enrolled at baseline, as part of study protocols approved and activated in the participating centers.
* Informed written consent.

Exclusion Criteria

* Inadequate compliance to multiple blood draws (baseline, 15 days, 1th month, 4th month, and/or at progression) as scheduled in this adjunctive biologic study for patients carrying B-FAF mutation; inadequate compliance to adjunctive blood draws, as scheduled at baseline for BRAF wild-type
* Previously exposure to immunological treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Diagnostics, LLC

INDUSTRY

Sponsor Role collaborator

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paola Zanovello, Phd

Role: PRINCIPAL_INVESTIGATOR

Padua University

Locations

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Vanna Chiarion-Sileni, MD

Padua, PD, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Vanna Chiarion-Sileni, MD

Role: CONTACT

0039 0498215931

Rita Zamarchi, MD

Role: CONTACT

0039 0498215873

Facility Contacts

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Vanna Chiarion-Sileni, MD

Role: primary

0039 0498215931

References

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Rao C, Bui T, Connelly M, Doyle G, Karydis I, Middleton MR, Clack G, Malone M, Coumans FA, Terstappen LW. Circulating melanoma cells and survival in metastatic melanoma. Int J Oncol. 2011 Mar;38(3):755-60. doi: 10.3892/ijo.2011.896. Epub 2011 Jan 3.

Reference Type BACKGROUND
PMID: 21206975 (View on PubMed)

Mocellin S, Hoon D, Ambrosi A, Nitti D, Rossi CR. The prognostic value of circulating tumor cells in patients with melanoma: a systematic review and meta-analysis. Clin Cancer Res. 2006 Aug 1;12(15):4605-13. doi: 10.1158/1078-0432.CCR-06-0823.

Reference Type BACKGROUND
PMID: 16899608 (View on PubMed)

Rossi E, Basso U, Celadin R, Zilio F, Pucciarelli S, Aieta M, Barile C, Sava T, Bonciarelli G, Tumolo S, Ghiotto C, Magro C, Jirillo A, Indraccolo S, Amadori A, Zamarchi R. M30 neoepitope expression in epithelial cancer: quantification of apoptosis in circulating tumor cells by CellSearch analysis. Clin Cancer Res. 2010 Nov 1;16(21):5233-43. doi: 10.1158/1078-0432.CCR-10-1449. Epub 2010 Oct 26.

Reference Type BACKGROUND
PMID: 20978147 (View on PubMed)

Rossi E, Fassan M, Aieta M, Zilio F, Celadin R, Borin M, Grassi A, Troiani L, Basso U, Barile C, Sava T, Lanza C, Miatello L, Jirillo A, Rugge M, Indraccolo S, Cristofanilli M, Amadori A, Zamarchi R. Dynamic changes of live/apoptotic circulating tumour cells as predictive marker of response to sunitinib in metastatic renal cancer. Br J Cancer. 2012 Oct 9;107(8):1286-94. doi: 10.1038/bjc.2012.388. Epub 2012 Sep 6.

Reference Type BACKGROUND
PMID: 22955853 (View on PubMed)

Mocellin S, Del Fiore P, Guarnieri L, Scalerta R, Foletto M, Chiarion V, Pilati P, Nitti D, Lise M, Rossi CR. Molecular detection of circulating tumor cells is an independent prognostic factor in patients with high-risk cutaneous melanoma. Int J Cancer. 2004 Sep 20;111(5):741-5. doi: 10.1002/ijc.20347.

Reference Type BACKGROUND
PMID: 15252844 (View on PubMed)

Other Identifiers

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CE IOV 2011/35

Identifier Type: OTHER

Identifier Source: secondary_id

IOV2011/35

Identifier Type: -

Identifier Source: org_study_id

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