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

NCT04025970 | Unknown DMC

• 1 other identifier: 2019-01410
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Germ line DNA, gDNA; Circulating tumor cell, CTC; Circulating cell free DNA, cfDNA, ctDNA; Screening; Diagnostic; Predictive

Outcome Measures

Primary Outcomes (1)

• Possibility of cellular and genomic sampling as part of the standardised care process

  Can blood samples be taken, processed in a timely manner and processed for isolation and analysis of circulating epithelial cells and free circulating DNA within the framework of the standardized care process for SCAN and CUP?

  1 month

Secondary Outcomes (1)

• Cellular and genomic sample analyses

  6 months

Study Arms (2)

Cancer of Unknown Primary (CUP)

Subjects referred, based on standardised criteria, for investigation and diagnosis for possible cancer of unknown primary (CUP). Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

Genetic: Circulating tumor cell and circulating tumor DNA test

Suspected CANcer (SCAN)

Subjects referred, based on standardised criteria, for investigation and diagnosis for suspected cancer (SCAN) based on serious non-specific symptoms and signs of cancer. Blood samples to be investigated for presence of circulating tumor cells and circulating tumor DNA.

Genetic: Circulating tumor cell and circulating tumor DNA test

Interventions

Circulating tumor cell and circulating tumor DNA test GENETIC

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

Cancer of Unknown Primary (CUP); Suspected CANcer (SCAN)

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden.

You may qualify if:

• patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden, for suspected cancer (SCAN) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (CUP) and which give informed consent to participate in the study.

You may not qualify if:

• All patients who have been referred and consented are included.

Sponsors & Collaborators

• Christer Ericsson: lead
• Karolinska Institutet: collaborator
• iCellate Medical: collaborator

Study Sites (1)

Diagnostiskt Centrum, Södertälje Sjukhus

Södertälje, Stockholm County, 152 86, Sweden

RECRUITING

Related Publications (4)

• Stenman E, Palmer K, Ryden S, Savblom C, Svensson I, Rose C, Ji J, Nilbert M, Sundquist J. Diagnostic spectrum and time intervals in Sweden's first diagnostic center for patients with nonspecific symptoms of cancer. Acta Oncol. 2019 Mar;58(3):296-305. doi: 10.1080/0284186X.2018.1537506. Epub 2019 Jan 11.

  PMID: 30632871 BACKGROUND

• Castro, J., Ericsson C., Cashin P., Mahteme H. Preliminary Finding: Detection of Circulating Cancer Cells in Blood from a Patient with Peritoneal Carcinomatosis Treated with Cytoreductive Surgery and Intraperitoneal Chemotherapy. Surgery: Current Research 2(3), 2012. doi: 10.4172/2161-1076.1000113

  BACKGROUND

• Castro, J., Sanchez, L., Alvarez Bedoya, P.H., Nunez, M.T., Lu, M., Castro, T., Sharifi, H.R., Ericsson, C. Screening Circulating Tumor Cells as a Non-invasive Cancer Test in 1,585 Asymptomatic Adults (ICELLATE1) J Integr Oncol 7(3), 2018 DOI 10.4172/2329-6771.1000212

  BACKGROUND

• Castro J, Sanchez L, Nunez MT, Lu M, Castro T, Sharifi HR, Ericsson C. Screening Circulating Tumor Cells as a Noninvasive Cancer Test in 3388 Individuals from High-Risk Groups (ICELLATE2). Dis Markers. 2018 May 28;2018:4653109. doi: 10.1155/2018/4653109. eCollection 2018.

  PMID: 29997714 BACKGROUND

Related Links

• The regional cancer centers of the public healthcare system will work to strengthen clinical cancer research in the region and in the country so that scientific advances will rapidly benefit cancer patients.

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples

MeSH Terms

Conditions

Neoplasms, Unknown Primary; Neoplasms; Neoplastic Cells, Circulating; Disease

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotta Savblom, MD, PhD

  Region Stockholm

  STUDY DIRECTOR

• Christer Ericsson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Soderholm, MD

CONTACT

08-550 24493; roland.soderholm@sll.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior scientist

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 19, 2019
• Study Start: September 30, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2021
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)