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Trial record 3 of 4 for:    sara pai

SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) (SUPREME-HN)

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ClinicalTrials.gov Identifier: NCT02543476
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor.

For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe.

Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional).

The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.


Condition or disease
Squamous Cell Carcinoma of the Head and Neck

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Study Type : Observational
Actual Enrollment : 412 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Actual Study Start Date : September 16, 2015
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
patients' group with tumor sample
SCCHN patients having available archived tumor sample(s).



Primary Outcome Measures :
  1. Prognosis of PD-L1 positive status in the patient population with available tumor sample [ Time Frame: From diagnosis to index day, expected to be up to 36 months ]
    PD-L1 status: positive-negative status measured on tumor slides. Positivity corresponds to more than 25% of tumor cells with membrane positivity for PD-L1. The primary objective of this study is to estimate the prognostic value of PD-L1 status in terms of OS in patients with recurrent/metastatic SCCHN


Secondary Outcome Measures :
  1. Exposure to risk factors - alcohol (e.g. Number of participants with alcohol consumption and amount of consumption per day) [ Time Frame: At index date, approximately +/- 2 months ]
    As recorded in the files. Measure of alcohol consumption in number of alcohol units per day. Patients will be categorized based on amount of consumption

  2. Exposure to risk factors - tobacco (e.g. Number of participants with current or past tobacco consumption and amount of consumption per day) [ Time Frame: At index date, approximately +/- 2 months ]
    As recorded in the files. Patients will be categorized according to smoking status at the index date and where available tobacco consumption in Pack years will be obtained from the files as recorded

  3. Exposure to risk factors - Human Immunodeficiency Virus (e.g. Number of participants positive for Human Immunodeficiency Virus) [ Time Frame: At index date, approximately +/- 2 months ]
    Positive/negative to Human Immunodeficiency Virus

  4. Exposure to risk factors - Human papillomavirus (e.g. Number of participants positive for Human papillomavirus) [ Time Frame: At index date, approximately +/- 2 months ]
    Positive/negative to Human papillomavirus

  5. Disease characteristics - performance status WHO criteria [ Time Frame: At index date approximately +/- 2 months ]
    Ranging from 0 to 4 (0: fully active; 4: completely disabled)

  6. Disease characteristics -performance status Karnofsky criteria [ Time Frame: At index date approximately +/- 2 months ]
    Ranging from 20 to 100 with increment of 10 (100: normal, 20: very sick, hospital admission necessary)

  7. Disease characteristics -performance status ECOG criteria [ Time Frame: At index date approximately +/- 2 months ]
    Ranging from 0 to 4 (0: fully active; 4: completely disabled)

  8. Lines of therapy description (e.g. Treatment lines patterns per participants' population) [ Time Frame: From First line therapy to end of data collection, expected to be up to 120 months ]
    Number of therapy lines and duration per patient: will be calculated based on start and stop dates of therapy. Treatment regimen will also be recorded

  9. Clinical outcomes -Best response to treatment line [ Time Frame: From First line therapy to end of data collection, expected to be up to 100 months ]
    The best response of patients whose cancer shrinks or disappears after treatment (as recorded, range from complete response to progression.)

  10. Clinical outcomes - Survival rate [ Time Frame: From index date to end of data collection, expected to be up to 85 months ]
    Time between index date and death/end of participation to study

  11. Complications (from second line therapy for recurrent/metastatic SCCHN) [ Time Frame: Complications (from second line therapy for recurrent/metastatic SCCHN) During or shortly after second line therapy, expected to be up to 3 months ]
    Characterization of most current complications related to treatment (from an existing list)


Biospecimen Retention:   Samples Without DNA
Archival tumor tissues samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have progressed on or after first line platinum-based chemotherapy regimen for recurrent/metastatic SCCHN and started second line therapy for recurrent/metastatic SCCHN between the 1st January 2010 and the 31st December 2014. Two parallel patient cohorts will be recruited for this study: patients with available tumor sample for determination of PD-L1 status at first and/or second line setting (independently of actual PD-L1 results), and patients without available tumor sample.
Criteria

Inclusion criteria:

1. Provision of subject informed consent (or consent from next of kin/legal representative if applicable) for use of the data and retrieval of tumor sample, according to local regulations 2. Adult patient (≥ 18 years old) 3. Patient with histologically confirmed SCCHN of oral cavity (tongue, gum, floor of mouth, other/unspecified part of the mouth), oropharynx, hypopharynx or larynx 4. Patient with recurrent or metastatic SCCHN diagnosed between 01 March 2011 and 30 June 2015 5. Mandatory archival tissue sample (most recent) from the primary site, a lymph node or a distant metastatic site:

  • Tissue sample less than 5 years old (compared to date of retrieval) if provided as complete block (preferred option) or as section cut within 60 days of shipment from site prior to testing 6. Optional archival tissue samples taken at other time points of the disease from the primary site, a lymph node or a distant metastatic site (where available):
  • Tissue sample less than 5 years old (compared to date of retrieval) if provided as complete block (preferred option) or as section cut within 60 days of shipment from site prior to testing.

Exclusion criterion:

1. Treatment for SCCHN with anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, or any other antibody with known immunomodulatory effect.


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): NCT02543476


Locations
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United States, California
Research Site
La Jolla, California, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Maryland
Research Site
Hyattsville, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, North Carolina
Research Site
Charlotte, North Carolina, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, South Dakota
Research Site
Sioux Falls, South Dakota, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United States, Texas
Research Site
Houston, Texas, United States
Germany
Research Site
Leipzig, Sachsen, Germany
Greece
Research Site
Athens, Greece
Italy
Research Site
Legnago (VR), Verona, Italy
Research Site
Milano, Italy
Japan
Research Site
Osaka-shi, Osaka-Fu, Japan
Research Site
Koto-ku, Tokyo-To, Japan
Korea, Republic of
Research Site
Seoul, Korea, Republic of
Spain
Research Site
Barcelona, Spain
Research Site
Sevilla, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Sara Pai, M.D., Ph.D. Massachusetts General Hospital
Principal Investigator: Ezra Cohen, M.D. University of California San Diego Moores Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02543476    
Other Study ID Numbers: D4193R00002
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by AstraZeneca:
PD-L1 status, biomarkers, prevalence, SCCHN, overall survival
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site