a PROspective Case Control Study to Develop and Validate a Blood Test FOr mUlti-caNcers Early Detection（PROFOUND）

Launched by SHANGHAI WEIHE MEDICAL LABORATORY CO., LTD. · Jan 11, 2024

Keywords

ClinConnect Summary

The PROFOUND trial is a research study that aims to create and test a new blood test designed to detect multiple types of cancer at an early stage. This study will collect blood samples from two groups of people: those who have recently been diagnosed with cancer and those who do not have a cancer diagnosis. By analyzing these samples, the researchers hope to develop a method that can help identify cancer earlier, which is crucial for improving treatment outcomes.

To participate in this study, individuals must be between 40 and 74 years old. Those in the cancer group should have a confirmed cancer diagnosis and not be undergoing any cancer treatments, while those in the control group should be healthy with no confirmed cancer. Participants will need to provide written consent and follow the study procedures. If you join, you can expect to provide a blood sample, which will be used to help advance cancer detection methods. This trial is currently recruiting participants, and being part of it could contribute to important advancements in cancer diagnosis and treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Case Arm Participants:
• • 40-74 years old
• • Clinically and/or pathologically diagnosed cancer
• • No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
• • Able to provide a written informed consent and willing to comply with all part of the protocol procedures
• Exclusion Criteria for Case Arm Participants:
• • Pregnancy or lactating women
• • Known prior or current diagnosis of other types of malignancies comorbidities
• • Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
• • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• • Recipients of blood transfusion within 30 days prior to screen
• • Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
• • Unsuitable for this trial determined by the researchers
• Inclusion Criteria for Control Arm Participants:
• • 40-74 years old
• • Without confirmed cancer diagnosis
• • Able to provide a written informed consent and willing to comply with all part of the protocol procedures
• Exclusion Criteria for Control Arm Participants:
• • Pregnancy or lactating women
• • Known prior or current diagnosis of other types of malignancies comorbidities
• • Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen
• • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• • Recipients of blood transfusion within 30 days prior to screen
• • Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
• • Unsuitable for this trial determined by the researchers