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The Circulating Cell-free Genome Atlas Study (CCGA)

This study is currently recruiting participants.
Verified November 2017 by GRAIL, Inc.
ClinicalTrials.gov Identifier:
First Posted: September 7, 2016
Last Update Posted: November 14, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
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 donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

Neoplasms Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Circulating Cell-free Genome Atlas Study

Further study details as provided by GRAIL, Inc.:

Primary Outcome Measures:
  • Evidence of histologically confirmed cancer in subjects with circulating tumor DNA (ctDNA) detected by deep sequencing. [ Time Frame: 18 months ]
    Clinically annotated plasma samples from cancer and non-cancer subjects will undergo deep sequencing to characterize cfNA profiles and to estimate the population heterogeneity in the two arms of the study.

Secondary Outcome Measures:
  • Number of genomic variants detected in plasma cfNA in cancer subjects who also have available tumor tissue. [ Time Frame: 18 months ]
    Concordance of variants identified in sequencing plasma cfNA and tumor tissue from the same subject will be evaluated.

  • Survival or clinical cancer status of all subjects with results from deep sequencing plasma cfNA. [ Time Frame: Year 1, 2, 3, 4, 5 ]
    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.

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

Estimated Enrollment: 10000
Study Start Date: August 2016
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Cancer arm
Subjects with new diagnosis of cancer (multiple tumor types) from which a blood sample and contemporaneous FFPE tumor tissue will be collected.
Non-cancer arm
Subjects with no known diagnosis or past history of cancer from which a blood sample will be collected.

Detailed Description:
This is a prospective, multi-center, observational study with collection of de-identified biospecimens and clinical data from at least 10,000 participants from clinical networks in the United States. The study will enroll at least 7000 cancer subjects with multiple solid tumor types (the CANCER arm) and at least 3000 representative subjects without a clinical diagnosis of cancer (the NON-CANCER arm). Cancer subjects with a new diagnosis and no prior systemic therapy will be recruited. Clinical data relevant to cancer status are collected from all participants and their medical record at baseline, and subsequently from the medical record at intermittent future time points, at least annually for up to 5 years. The study test(s) to be used in this protocol are next generation sequencing (NGS)-based assay(s) that are under investigation and development at GRAIL.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 20 years or older
  • Able to provide a written informed consent and who understand and agree to all study procedures required

Cancer arm:

  1. Either of the following:

    • Diagnosis of histologically confirmed cancer present in the patient (any stage I-IV, as well as carcinoma in situ (CIS)), with no prior systemic cancer therapy and scheduled for surgical resection or non-surgical management OR,
    • Subjects with a high suspicion for cancer diagnosis by clinical and radiological assessment, but without preceding histologic diagnosis, are eligible if they have not received prior systemic cancer therapy and are scheduled for surgery or biopsy to retrieve cancer tissue
  2. Has or will have a medically obtained pathological tumor specimen from core needle or other biopsy or removal of a metastatic mass or node within 90 days prior to study blood draw and/or planned surgical resection within 6 weeks (42 days) after study blood draw and pre-treatment.

Non-Cancer arm:

● Male and female adults with no known prior or current diagnosis of cancer, except non-melanomatous skin cancer.

Exclusion Criteria:

● Currently receiving or ever received any of the following cancer therapies: curative surgical resection, local or systemic chemotherapy, targeted therapy, immunotherapy including cancer vaccines, hormone therapy, or radiation therapy

  • Oral or IV corticosteroids in past 14 days for non-cancer subjects
  • Pregnancy (by self-report of pregnancy status)
  • Current febrile illness
  • Acute exacerbation or flare of an inflammatory condition requiring escalation in therapy
  • 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
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

Contact: Richard Williams, MBBS PhD rwilliams@grailbio.com

  Show 116 Study Locations
Sponsors and Collaborators
Study Director: Richard Williams, MBBS PhD GRAIL, Inc.
  More Information

Responsible Party: GRAIL, Inc.
ClinicalTrials.gov Identifier: NCT02889978     History of Changes
Other Study ID Numbers: GRAIL-001
First Submitted: August 18, 2016
First Posted: September 7, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by GRAIL, Inc.:
Cancer Screening
High-Throughput Nucleotide Sequencing
Deep Sequencing
Circulating cell-free tumor DNA