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Circulating Tumor Cells in Non-Small Cell Lung Carcinoma (LDx)

20 januari 2016 bijgewerkt door: Epic Sciences

Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma

The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.

Studie Overzicht

Toestand

Voltooid

Conditie

Primaire longkanker

Studietype

Observationeel

Inschrijving (Werkelijk)

232

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- California
  - La Jolla, California, Verenigde Staten, 92093
    - Moores Cancer Center
- Connecticut
  - New haven, Connecticut, Verenigde Staten, 06510
    - Yale University
- Montana
  - Billings, Montana, Verenigde Staten, 59101
    - Billings Clinic Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

19 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

A primary lung cancer bearing population will be studied. Eligible patients will include those presenting to the specified clinical centers with a tissue confirmed primary lung cancer or radiographic abnormality deemed highly suspicious for primary lung cancer by collaborating clinical team, in whom definitive tissue diagnosis is planned. All stages of primary lung cancer will considered.

Beschrijving

Inclusion Criteria:

Suspected lung cancer
Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
Age >18

Exclusion Criteria:

Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
Inability to provide informed consent.
Hgb less than 8.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Case-control
Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
CTC Enumeration Tijdsspanne: 3 months from baseline, an average of 2 weeks post patient tissue biopsy	After informed consent of the patients, a single tube of blood will be drawn and processed according to the standard protocol. These blood draws will occur upon patient screening or rather the baseline of their treatment, a 6-12 week follow-up, as well as a 12 month follow-up.Furthermore, a biopsy will be taken between baseline and 6-12 week follow-up which will be used upon results of CTC enumeration to illustrate concordance. Epic Sciences staff is fully blinded to the clinical data of the patients until final analysis. Patients will be considered CTC positive at a count of greater than 2 CTCs per ml of blood.	3 months from baseline, an average of 2 weeks post patient tissue biopsy

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Lung Cancer Subtyping Tijdsspanne: 3 months from baseline, an average of 2 weeks post patient tissue biopsy	Based on the blood draws from the primary outcome, Epic will utilize the identified CTCs as biopsy material for lung cancer subtyping that distinguishes between adenocarcinoma (ACA), squamous cell carcinoma (SCC) from other types of primary lung cancer. Lung cancer histology will be evaluated for each patient sample: Two slides will be run with the ACA-CTC assay (TTF1 or Napsin A) and two slides will be run with the SCC-CTC (p63) assay. For the purpose of assay development and validation, we have all already procured a validated set of patient samples with known histology.	3 months from baseline, an average of 2 weeks post patient tissue biopsy
Nodal Staging Tijdsspanne: 3 months from baseline, an average of 2 weeks post patient tissue biopsy	For patients ultimately diagnosed with lung cancer and deemed to be surgical candidates, surgical intervention will be performed. In accordance to a standard practice mediastinal lymph node dissection will accompany the surgery. Nodal staging for each patient in the trial with diagnosed lung cancer will be evaluated clinically and pathologically. Clinical staging will be determined by the treating clinician prior to information being available from surgery and recorded in the case report form. The diagnostic accuracy of the clinical stage will be determined by comparison with the pathological stage which will be abstracted from the pathology report for surgically staged patients. We will determine the sensitivity and specificity of the CTC count as a test that identifies patients who will ultimately be "upstaged" from N0 to N1 or from N1 to N2-3 at the time of surgical staging when comparing the clinical and pathological stage.	3 months from baseline, an average of 2 weeks post patient tissue biopsy
Establish the Prognostic Value by measuring CTC count over time. Tijdsspanne: Baseline, 3 months, 24 months and 66 months	This measure will work to establish the prognostic value of the initial test by drawing the correlation with outcome data. For the 260 patients recruited to this clinical trial, stage specific Kaplan-Meier overall and disease free survival curves for the population will be generated after 2 years of follow-up. For each stage, the results of the CTCs will then be used to separate the population for each stage into a low CTC and high CTC group to determine if the disease free survival curves for each stage separate on the basis of the assay and are statistically significant using a retrospective analysis of the prospectively collected data, this will determine if knowledge of the CTC assay provides useful information about disease free survival beyond that which is obtained by clinical staging alone.	Baseline, 3 months, 24 months and 66 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Epic Sciences

Medewerkers

National Cancer Institute (NCI)

University of California, San Diego

Yale University

Billings Clinic

Onderzoekers

Hoofdonderzoeker: Ryan Dittamore, MBA, Epic Sciences

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2012

Primaire voltooiing (Werkelijk)

1 december 2015

Studie voltooiing (Werkelijk)

1 januari 2016

Studieregistratiedata

Eerst ingediend

25 maart 2013

Eerst ingediend dat voldeed aan de QC-criteria

11 april 2013

Eerst geplaatst (Schatting)

12 april 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

22 januari 2016

Laatste update ingediend die voldeed aan QC-criteria

20 januari 2016

Laatst geverifieerd