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NCT05219734Active, not recruiting

MRD Assay Evaluates Recurrence and Response Via a Tumor Informed Assessment

Source: ClinicalTrials.gov · Last updated 12 Mar 2024

Brief summary (registry, in English)

This study recruits patient with solid tumor types for sample collection and monitoring. Participants will provide blood and archival tissue samples in order to create a Personalized Cancer Monitoring (PCM) assay. This assay will be used to detect circulating tumor DNA (ctDNA) levels in the blood over time and hopefully contribute to improvements in residual disease detection methods for future patients. Results from this assay will be provided to participants and providers but providers are not asked to change patient care based on this information.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
20 Dec 2021
Start date
29 Nov 2021
Primary completion date
Dec 2026
Lead sponsor
Invitae Corporation
NCT number
NCT05219734

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 29 Nov 2021 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants diagnosed with CNS cancers, sarcomas or hematologic malignancies such as leukemia or lymphoma .
  • Participants with more than one primary cancer

Age

  • Participants who are \<18 years of age
  • Participants with FFPE slides older than 10 years

Other

  • Participants who are deemed medically unstable
  • Participants who are deemed to be "difficult to draw" blood from.
  • Participants who are pregnant
  • Any other reason that, in the Investigator's judgment, that would preclude the participant from being able to participate in the study
  • Participants for which a pathology report is not available

Who the study is looking for

  • Stated ability to give informed consent by participant.
  • Stated health status of participant as healthy enough to provide Biological Material.
  • Individuals diagnosed with solid cancer of any type, including but not limited to colorectal, non-small cell lung, breast, ovarian and bladder cancers, regardless of the length of time since diagnosis and regardless of previous therapies.
  • Participant is of any biological sex and \>18 years of age
  • Participant has not undergone a blood transfusion within the previous three weeks

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Columbus Regional Health
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Onslow Radiation
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.