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Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

NCT04025970 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2019-10-04

No results posted yet for this study

Summary

Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies.

New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients.

Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA.

As a reference, germ-line DNA will also be sampled, also from regular blood samples.

The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced.

The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.

Conditions

  • Neoplasms, Unknown Primary
  • Cancer

Interventions

GENETIC

Circulating tumor cell and circulating tumor DNA test

Patient stratification based on presence or absence of suspicious findings of cells and DNA

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • iCellate Medical

    collaborator INDUSTRY

  • Christer Ericsson

    lead OTHER_GOV

Principal Investigators

  • Charlotta Savblom, MD, PhD · Region Stockholm

  • Christer Ericsson, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Max Age
125 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025970 on ClinicalTrials.gov