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Trial record 1 of 1 for:    sllip
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Spanish Lung Liquid vs. Invasive Biopsy Program (SLLIP) (SLLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03248089
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
GUARDANT HEALTH
Information provided by (Responsible Party):
MedSIR

Brief Summary:
Tumor Derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The primary objective of this study is to demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping.

Condition or disease Intervention/treatment
Lung Cancer Diagnostic Test: Guardant360

Detailed Description:

Primary objective:

To demonstrate the non-inferiority of cfDNA-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve, metastatic non-squamous NSCLC.

The following secondary objectives will be studied:

  • Turn around Time (TAT) of cfDNA vs. tissue results.
  • Time to treatment (TtT) initiation.
  • Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing.
  • Tumor Not Detected (TND) rate of cfDNA in blood.
  • Rescue rate of QNS samples using cfDNA-derived genotyping.
  • Rate response for patients that are actionable biomarker positive (either in cDNA or tissue) treated with target-drugs according investigator criteria. Up to three RECIST assessments per patient will be retrospectively done by external personnel (no investigational team).
  • Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.

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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Other
Time Perspective: Other
Official Title: Spanish Lung Liquid vs. Invasive Biopsy Program
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy


Intervention Details:
  • Diagnostic Test: Guardant360
    Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.


Primary Outcome Measures :
  1. Non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping [ Time Frame: From date of inclusion until 12 months from enrollment follow-up or upon progression, death or withdrawal from study participation, whichever occurs first. ]
    Demonstrate the non-inferiority of cell free DNA (cfDNA)-based versus tumor tissue-based genotyping as it pertains to the detection of clinically-actionable biomarkers in first line, treatment naïve, metastatic non-squamous Non-small cell lung cancer (NSCLC).


Secondary Outcome Measures :
  1. Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results [ Time Frame: From pre-treatment visit until month 12 or upon progression, whichever occurs first ]
    Turn around Time (TAT) of cell free DNA (cfDNA) vs. tissue results

  2. Time to treatment (TtT) initiation [ Time Frame: From the date of enrollment in the study until D1 (treatment initiation) ]
    Time to treatment (TtT) initiation

  3. Quantity not sufficient rate (QNS) of tissue [ Time Frame: From day 0 to pre-treatment visit ]
    Quantity not sufficient rate (QNS) of tissue for clinically-actionable biomarker testing

  4. Tissue Incomplete (TI) rate of tissue [ Time Frame: From day 0 to pre-treatment visit ]
    Tissue Incomplete (TI) rate of tissue for National Cancer Center Network (NCCN) biomarker testing

  5. Tumor Not Detected (TND) rate of cell free DNA (cfDNA) [ Time Frame: From pre-treatment visit until month 12 or upon progression, whichever occurs first ]
    Tumor Not Detected (TND) rate of cell free DNA (cfDNA) in blood

  6. Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping [ Time Frame: From pre-treatment visit until month 12 or upon progression, whichever occurs first ]
    Rescue rate of Quantity not sufficient (QNS) samples using cell free DNA (cfDNA)-derived genotyping

  7. Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs [ Time Frame: From visit 0 until month 12 or upon progression, whichever occurs first ]
    Rate response for patients that are actionable biomarker positive (either in cell DNA (cDNA) or tissue) treated with target-drugs according investigator criteria.

  8. Rate of discovery of genomically mediated, acquired resistance to targeted therapies [ Time Frame: From visit 0 until month 12 or upon progression, whichever occurs first ]
    Rate of discovery of genomically mediated, acquired resistance to targeted therapies in the biomarker-positive subsets.


Biospecimen Retention:   Samples With DNA

Approximately 20 mL of peripheral blood will be collected in StreckTM tubeS. cfDNA will be drawn following blood withdraws following standard of care of the participating site, which would be, before treatment (v2); on the same date as the first standard of care labs (V3), which would be approximately 2 weeks (14 days) into first-line treatment and after one year from enrollment or upon progression whichever occurs first (EoS visit).

enrollment or upon progression whichever occurs first (EoS visit).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
182 patients with previously untreated non-small cell lung cancer (NSCLC), non-squamous subtype will be recruited for this study, wherein Cell free DNA (cfDNA) will be compared to biopsy-based tumor sequencing
Criteria

Inclusion Criteria:

  • Patients biopsy-proven, metastatic, previously untreated, non-squamous non-small cell lung cancer (NSCLC). Patients may have received adjuvant cytotoxic chemotherapy, but not targeted neo-adjuvant or adjuvant therapy.
  • Age ≥ 18 years
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Willingness to provide blood sample at the time points defined in Table 1 [pre-treatment, Day 14 (+/- 7 days) and End of Study].
  • Patient has or will have standard-of-care tissue genotyping ordered.
  • Stable Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Pregnancy, recorded from clinical records
  • Any concurrent, non-cutaneous, malignancy (with the exception of early stage non-invasive cervical cancer). Any prior cancer must have occurred more than 5 years prior with no evidence of currently active disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248089


Locations
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Spain
H. Can Ruti
Badalona, Spain
Dexeus
Barcelona, Spain
H. del Mar
Barcelona, Spain
H. Sant Pau
Barcelona, Spain
H. Vall Hebrón
Barcelona, Spain
ICO Bellvitge
L'Hospitalet de Llobregat, Spain
H. Arnau de Vilanova
Valencia, Spain
Sponsors and Collaborators
MedSIR
GUARDANT HEALTH
Investigators
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Principal Investigator: Rafael Rosell IOR
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Responsible Party: MedSIR
ClinicalTrials.gov Identifier: NCT03248089    
Other Study ID Numbers: MedOPP125
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No