Bespoke Pan Cancer
Hristos Kaimakliotis, MD
Primary Investigator
Brief description of study
This is a prospective, multi-center, single arm study focused on data and sample collection from participants diagnosed with Stage I to IV cancers and for whom standard of care Natera MRD
testing has been ordered (for example, SignateraTM, SignateraTM Genome, or LatitudeTM). This study will utilize study sites located within the United States of America (USA). The primary objective is to establish a comprehensive data repository to support the development and validation of cancer monitoring and detection tests. The goal of this study is to clinically characterize biomarkers associated with development and validation of cancer monitoring and detection tests (“Natera cancer monitoring and detection test(s)”). The primary endpoint of this study is to obtain anonymized clinical data from up to 5,000 participants.
Detailed description of study
The study will enroll participants for up to 36 months, with each participant followed for up to 5 years after enrollment. Total study duration will be approximately eight (8) years from the first participant enrolled to the last participant’s final visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Primary malignancy, Solid tumor, Hematologic malignancies, Cancer
-
Age: 18 years - 100 years
-
Gender: All
Participants must meet all the following selection criteria to be eligible for the
study.:
1. 18 years of age or older
2. Participant has a primary malignancy including any solid tumor and
hematologic malignancies
3. Selected by their treating physician to undergo serial testing with a
clinically-available Natera MRD test according to the current evidence-
informed schedule
4. Signed informed consent(s) must be obtained prior to participation in the
study
5. Willing and able to comply with the study requirements
Participants are not eligible for the study if they meet any of the following
criteria, as assessed by the Site Investigator:
1. Pregnant or breastfeeding
2. History of bone marrow or organ transplant
3. Serious medical conditions that may adversely affect ability to
participate in the study
Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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