- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01830426
Circulating Tumor Cells in Non-Small Cell Lung Carcinoma (LDx)
20 januari 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
232
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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La Jolla, California, Förenta staterna, 92093
- Moores Cancer Center
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Connecticut
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New haven, Connecticut, Förenta staterna, 06510
- Yale University
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Montana
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Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
CTC Enumeration
Tidsram: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
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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.
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3 months from baseline, an average of 2 weeks post patient tissue biopsy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Lung Cancer Subtyping
Tidsram: 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.
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3 months from baseline, an average of 2 weeks post patient tissue biopsy
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Nodal Staging
Tidsram: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
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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.
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3 months from baseline, an average of 2 weeks post patient tissue biopsy
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Establish the Prognostic Value by measuring CTC count over time.
Tidsram: Baseline, 3 months, 24 months and 66 months
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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.
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Baseline, 3 months, 24 months and 66 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ryan Dittamore, MBA, Epic Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2012
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
25 mars 2013
Först inskickad som uppfyllde QC-kriterierna
11 april 2013
Första postat (Uppskatta)
12 april 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 januari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Neoplastiska processer
- Neoplasma Metastas
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Neoplastiska celler, cirkulerande
Andra studie-ID-nummer
- HHSN261201200049C
- HHSN26120100049C (Annat bidrag/finansieringsnummer: National Cancer Institute)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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