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The Circulating Cell-free Genome Atlas Study (CCGA)

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: NCT02889978
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
GRAIL, LLC

Study Description
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Brief Summary:
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from participants with a new diagnosis of cancer (blood and tumor tissue) and from participants who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer participants and to develop models for distinguishing cancer from non-cancer.

Condition or disease
Neoplasms Cancer

Detailed Description:
This is a prospective, multi-center, observational study with collection of de-identified biospecimens and clinical data from at least 15,000 participants from clinical networks in the United States and Canada. The study will enroll approximately 10,500 cancer participants (CANCER arm) and approximately 4,500 representative participants without a clinical diagnosis of cancer (NON-CANCER arm). Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (time of biospecimen collection), and subsequently from the medical record at intermittent future time points, at least annually for up to 5 years.
Study Design
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Study Type : Observational
Actual Enrollment : 15254 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Circulating Cell-free Genome Atlas Study
Actual Study Start Date : August 4, 2016
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024
Groups and Cohorts
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Group/Cohort
Cancer arm
Participants with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.
Non-cancer arm
Participants with no known diagnosis or past history of cancer from which a blood sample will be collected.


Outcome Measures
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Primary Outcome Measures :
  1. To collect and study clinically-annotated biospecimens, specifically peripheral blood and contemporary tumor tissue when available, to characterize cfNA profiles from deep sequencing and to estimate the population heterogeneity in two arms of the study. [ Time Frame: 30 months ]
  2. To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. [ Time Frame: 30 months ]
  3. To evaluate concordance of variants identified in sequencing of tumor tissue and cfNA sequencing results in plasma from the same subject. [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. To explore the relationship between genomic results and clinical outcomes based on collection of longitudinal information (at least annually for up to 5 years) from medical records for all consenting participants. [ Time Frame: Year 1, 2, 3, 4, 5 ]
  2. To enable assessment of the performance of an analytically validated clinical laboratory version of the NGS assay (under development) to detect circulating tumor DNA (ctDNA) in plasma. [ Time Frame: Year 1, 2, 3, 4, 5 ]

Biospecimen Retention:   Samples With DNA
Plasma, white blood cells, formalin fixed, paraffin embedded (FFPE) tumor tissue

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Eligible study participants will be recruited from participating medical centers in a ratio of 3 non-cancer participants for every 7 cancer participants within each individual research center. Non-cancer subject recruitment will be monitored to achieve demographic characteristics (eg, age, gender, ethnicity, smoking status) reflective of those of the cancer participants.
Criteria

Inclusion Criteria for Non-Cancer Arm Participants:

  • Age 20 years or older
  • Able to provide a written informed consent

Exclusion Criteria for Non-Cancer Arm Participants:

  • Known current or prior diagnosis of cancer except non-melanoma skin cancer
  • Oral or IV corticosteroid use in past 14 days prior to blood draw
  • Pregnancy (by self-report)
  • Current febrile illness
  • Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
  • Poor health status or unfit to tolerate blood draw

Inclusion Criteria for Cancer Arm Participants:

  • Age 20 years or older
  • Able to provide a written informed consent

Have either of the following:

A. Confirmed cancer diagnosis (any stage I-IV, as well as carcinoma in situ (CIS) within 90 days prior to or up to 42 days after study blood draw, based upon assessment of a pathological specimen

OR

B. A high suspicion for a cancer diagnosis by clinical and/or radiological assessment, with planned biopsy or surgical resection to establish a definitive diagnosis within 6 weeks (42 days) after study blood draw

Exclusion Criteria for Cancer Arm Participants:

  • Known prior diagnosis of cancer except non-melanoma skin cancer
  • Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy
  • Pregnancy (by self-report)
  • Current febrile illness
  • Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw.
  • Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
  • Poor health status or unfit to tolerate blood draw
Contacts and Locations
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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): NCT02889978


Locations
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Sponsors and Collaborators
GRAIL, LLC
Investigators
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Study Director: Kathryn N Kurtzman, MD GRAIL, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GRAIL, LLC
ClinicalTrials.gov Identifier: NCT02889978    
Other Study ID Numbers: GRAIL-001
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Keywords provided by GRAIL, LLC:
Cancer Screening
High-Throughput Nucleotide Sequencing
Deep Sequencing
Circulating cell-free tumor DNA