NCT01878396

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

June 7, 2013

Last Update Submit

September 30, 2016

Conditions

Metastatic Melanoma

Keywords

Circulating Melanoma cells in metastatic melanoma

Outcome Measures

Primary Outcomes (1)

  • Change of CMC count during treatment and comparison with CT and PET

    24 months

Study Arms (1)

Mutated Anti-B-RAF

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

Drug: Anti-B-RAF

Interventions

Anti-B-RAFDRUG
Mutated Anti-B-RAF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanna Chiarion-Sileni, MD

Padua, PD, 35128, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21206975BACKGROUND

  • 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.

    PMID: 16899608BACKGROUND

  • 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.

    PMID: 20978147BACKGROUND

  • 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.

    PMID: 22955853BACKGROUND

  • 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.

    PMID: 15252844BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Paola Zanovello, Phd

    Padua University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanna Chiarion-Sileni, MD

CONTACT

0039 0498215931mgaliz@tiscali.it

Rita Zamarchi, MD

CONTACT

0039 0498215873rita.zamarchi@unipd.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2013

First Posted

June 17, 2013

Study Start

December 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

IT(1)