We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02889978
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
GRAIL, Inc.

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 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.

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 subjects with multiple types of malignancies (CANCER arm) and approximately 4,500 representative subjects 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. 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.

Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Circulating Cell-free Genome Atlas Study
Study Start Date : August 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2023

Group/Cohort
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.



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: 24 months ]
  2. To develop and evaluate models for discriminating cancer versus non-cancer and tissue of origin. [ Time Frame: 24 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: 24 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 subjects. [ 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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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 subjects.
Criteria

Inclusion Criteria for Non-Cancer Arm Subjects:

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

Exclusion Criteria for Non-Cancer Arm Subjects:

  • 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 Subjects:

  • 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 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 Subjects:

  • 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

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


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

  Show 140 Study Locations
Sponsors and Collaborators
GRAIL, Inc.
Investigators
Study Director: Richard Williams, MBBS PhD GRAIL, Inc.

Responsible Party: GRAIL, Inc.
ClinicalTrials.gov Identifier: NCT02889978     History of Changes
Other Study ID Numbers: GRAIL-001
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

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