Circulating Tumor DNA as Marker for Response to Antineoplastic Treatment of Metastatic Cancer (FLUIDO)

NCT04793061 | Unknown

• 1 other identifier: FLUIDO-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Early monitoring of antineoplastic treatment benefit is a central medical need. Radiologic assessment for documentation of response is done after several months of treatment usually. This implies that patients not responding are exposed to unnecessary toxicity. According to several reports showing the correlation of the amount of circulating tumour DNA with tumour burden we aim to investigate its early dynamic change at the beginning and during antineoplastic treament until radiologic response assessment. Blood samples necessary for that are taken within the scope of clinical routine care. We hypothesize that the changes of circulating tumour DNA correlate with the radiological findings.

Conditions

Metastatic Cancer

Keywords

metastatic cancer, circulating tumor DNA, treatment, response prediction

Outcome Measures

Primary Outcomes (1)

• ctDNA dynamics correlate with response to antineoplastic treatment

  ctDNA concentration in peripheral blood will drop if patient respond to treatment

  3 months per patient

Interventions

blood sample collection OTHER

Blood is samples from peripheral vein during routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic cancer who are treated with antineoplastic treatment are eligible if a molecular marker is either known due to the type of cancer (Case A) or if a molecular marker is known due to routine assessment (Case B). An example for "Case A" is pancreatic cancer, which is known to harbor KRAS-mutations as part of tumorigenesis in more than 90% (8), or multiple cancers harboring methylated WIF(9). A typical example for "Case B" is colorectal or gastric cancer. Systemic treatment requires the knowledge of the mutational status of RAS, EGFR and BRAF, which is assessed routinely from tumor tissue. If a mutation is found the patient qualifies for participation in the project. We finally plan to include at least 40 patients with mPDAC, another 40 patients with mCRC and 20 patients with mGC (100 patients in total at least).

You may qualify if:

• Metastatic cancer (mPDAC, mGC, mCRC)
• Known mutation of the cancer
• Signed informed consent
• At least 18 years
• Eligible for antineoplastic treatment

Sponsors & Collaborators

• Elisabethinen Hospital: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

Ordensklinikum Linz

Linz, Upper Austria, 4020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for isolation of cell free DNA for the detection of circulating tumor specific DNA

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head GI-Cancer Center

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 11, 2021
• Study Start: April 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)