Current Clinical Trials

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
  1. Constantin Dasanu, MD, PhD
    Constantin Dasanu, MD, PhD
  2. for people 40 Years to 75 Years (full criteria)
  3. Rancho Mirage, CA
  4. study started August 2022
  5. Constantin Dasanu, MD, PhD
  6. Accepting new patients

Description

Summary

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

Official Title

Alliance A212102: Blinded Reference Set for Multicancer Early Detection (MCED) Blood Tests aka Alliance MCED Biobank Study

Detailed Description

PRIMARY OBJECTIVE: I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection. SECONDARY OBJECTIVES: I. Evaluate test performance at the time of initial cancer diagnosis by tumor type. II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage. OUTLINE: Participants complete a questionnaire at bas... more
less

PRIMARY OBJECTIVE: I. To provide a blinded reference set of cancer versus (vs.) non-cancer blood samples that will be used to validate assays for inclusion in a prospective clinical trial focused on utility of blood-based multi-cancer early detection. SECONDARY OBJECTIVES: I. Evaluate test performance at the time of initial cancer diagnosis by tumor type. II. Evaluate test performance at the time of initial cancer diagnosis by clinical stage. OUTLINE: Participants complete a questionnaire at baseline. Participants undergo collection of blood samples at registration and at 12 months after registration. Patients with a cancer diagnosis may undergo collection of tissue samples at registration and 12 months after registration. After completion of study, participants are followed up at 1 year.

Keywords

Acute Lymphoblastic Leukemia

Eligibility

for people 40 Years to 75 Years
Inclusion Criteria: Participants with a cancer diagnosis: Documentation of disease: Histologic documentation: Histologically confirmed diagnosis of invasive cancer Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia [AML]) For lymphoma: Stage I-IV bas... more
less

Inclusion Criteria: Participants with a cancer diagnosis: Documentation of disease: Histologic documentation: Histologically confirmed diagnosis of invasive cancer Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma For leukemia: Type (chronic lymphocytic leukemia [CLL], chronic myeloid leukemia [CML], acute lymphoblastic lymphoma [ALL], acute myeloid leukemia [AML]) For lymphoma: Stage I-IV based on Ann Arbor staging For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS) One of the following tumor types: Colorectal Bladder Head and neck Hepatobiliary Lung Lymphoma Leukemia Ovary *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment Pancreas *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment Multiple myeloma Gastric, esophageal or gastroesophageal Breast Thyroid Kidney For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment Endometrium Prostate Melanoma *** For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment Sarcoma Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention Participants with a cancer diagnosis: Age >= 40 and =< 75 Participants with a cancer diagnosis: No known current pregnancy by self-report Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis Participants with a cancer diagnosis: Willingness to provide blood samples for research use Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL Participants with a cancer diagnosis: No history of organ transplantation Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages Participants without a cancer diagnosis and without suspicion of cancer: Age >= 40 and =< 75 Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw * Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs Participants with a high suspicion of cancer: Age >= 40 and =< 75 Participants with a high suspicion of cancer: No known current pregnancy by self-report Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis Participants with a high suspicion of cancer: Willingness to provide blood samples for research use Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL Participants with a high suspicion of cancer: No history or organ transplantation Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish * Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

Lead Scientists at Eisenhower Health

Constantin Dasanu, MD, PhD
Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicin... more
less

Board Certified Medical Oncologist and Hematologist, Constantin Dasanu, MD, PhD, is dedicated to providing personalized cancer care for his patients and their families. He received his M.D. degree summa cum laude from the Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, Moldova, and his Ph.D. in Immunology from the Carol Davila University of Medicine and Pharmacy, Bucharest, Romania. He completed his residency in Internal Medicine at the Albert Einstein College of Medicine in New York and his fellowship in Hematology/Oncology at New York Medical College. Dr. Dasanu also completed his training in Hematology & Transfusion Medicine in his home country Romania. 

“My immunology background offers me a unique clinical perspective as contemporary cancer therapies include a multitude of targeted agents, monoclonal antibodies, various biologics and vaccines,” states Dr. Dasanu. He treats patients with a variety of solid cancers, malignant melanoma and blood conditions. He serves as Director of Hematologic Malignancies at Eisenhower Lucy Curci Cancer Center (ELCCC). 

Dr. Dasanu is a Clinical Professor of Medicine at the University of California in San Diego, a major collaborative affiliate of ELCCC. He is the Director of Research at ELCCC and a principal investigator for a number of clinical trials. He presents his research findings at national and international conferences. He is the recipient of several teaching awards including the prestigious Thomas R. Preston MD Excellence in Teaching Award at the University of Connecticut in 2011. 

A prolific medical writer, Dr. Dasanu published more than 200 scientific and scholarly articles in prominent specialty journals including Journal of Clinical Oncology, New England Journal of Medicine, Journal of Thoracic Oncology and British Journal of Haematology among others. He is the editor of oncology sections at the Expert Opinion on Pharmacotherapy, Expert Opinion on Biological Therapy, and Current Medical Research and Opinion. He is a peer reviewer for Blood Journal and Leukemia Research. 

Armed with the knowledge of science, Dr. Dasanu feels that he can make a real difference in the lives of his patients. “The field is constantly changing and, therefore, I keep learning and constantly applying the most up-to-date, state-of-the-art treatments which ultimately benefit my patients,” states Dr. Dasanu. “My role is one of providing my patients with a medical plan that offers hope, but not false hope. Treating patients as unique individuals, with respect and compassion, and treating them as I would want to be treated are my ultimate goals in patient care.”

Clinical Study Details

  1. Accepting new patients
  2. study started August 2022
  3. Observational
  4. March 28, 2024