Pan-tumor MRD Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorParadigm Health

About this trial

The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back.

Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1).

Eligible for curative intent therapy, with surgical resection of cancer planned.

Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.

Disqualifiers

None

Trial population

Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood and tissue samples

    Diagnostic test

    routine standard of care

  • blood and tissue samples

    Other intervention

    Routine standard of care

Treatment groups

1,350 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)2 interventions
Group B: Esophageal2 interventions
Group C: Gastric and Gastroesophageal Junction (GEJ)2 interventions
Group D: Melanoma2 interventions
Group E: Non-small cell lung (NSCLC)2 interventions
Group F: Pancreatic (exocrine only)2 interventions
Group G: Mix of Solid Tumors (MOST)2 interventions

Trial outcomes

Primary outcomes

1

Blood and tissue biospecimen registry

To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.

Time frame
Observation from enrollment to 5.5 years after enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

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