Clinical Trials

Current Clinical Trials

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection. A212102: Multicancer Early Detection (MCED)
  1. Henry Tsai, MD
    Henry Tsai, MD
  2. for people 40 Years to 75 Years (full criteria)
  3. Rancho Mirage, CA
  4. study started August 2022
  5. Henry Tsai, MD
  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. Open Cohorts: o Colorectal – White Participants: Stage 1, Non-White: Stage 1-4 o Lung – Non-White Participants: Stage 1-3 o Pancreas – White Participants: Stage 3, Non-White: Stage 1-4 & Unknown Stage o Breast – Non-White Participants: Stage 3-4 o Ovarian – Stage 1-3 o Kidney – Stage 2-3 o Multiple Myeloma – Stage 3 o Esophageal or Gastroesophageal – Stage 1 o Bladder – Stage 1, 3, 4 o Hepatobiliary – Stage 1-3 o Leukemia CML, ALL, & AML o Endometrial - Stage 2-3 o Non-White Male Participants WITHOUT a Cancer Diagnosis Age 60-75

Official Title

Alliance A212102: Blinded Reference Set for Multicancer Early Detection (MCED) Blood Tests aka Alliance MCED Biobank Study. Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection.

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
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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
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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

Henry Tsai, MD
For Henry Tung-Yun Tsai, MD, MA, a Board Certified Hematologist and Medical Oncologist – specializing in the treatment colon cancer and other gastrointestinal cancers, medicine has always been a part of his life. Originally from Taiwan, Dr. Tsai’s father and sisters all have careers in medicine – ranging in specialties from pharmacy to general surgery. After having moved from Taiwan at age 14, Dr. Tsai attended the University of California at Berkeley ... more
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For Henry Tung-Yun Tsai, MD, MA, a Board Certified Hematologist and Medical Oncologist – specializing in the treatment colon cancer and other gastrointestinal cancers, medicine has always been a part of his life. Originally from Taiwan, Dr. Tsai’s father and sisters all have careers in medicine – ranging in specialties from pharmacy to general surgery. 

After having moved from Taiwan at age 14, Dr. Tsai attended the University of California at Berkeley where he received his Bachelor of Arts in molecular and cell biology/neurobiology. He received a Master of Arts degree in medical sciences from Boston University and attended medical school at Wayne State University School of Medicine in Detroit, Michigan.

Upon graduating from medical school, he moved to Atlanta, Georgia for an internship, residency and a fellowship in Hematology/Oncology at Emory University. It was at Emory where Dr. Tsai grew to love his chosen specialty: cancer care.

“Yes, cancer care is one of the most difficult fields to practice,” says Dr. Tsai. “But, it is also the most stimulating and rewarding. There are days when I see my patients get better and I have experienced hope. I feel privileged to be a part of their process.”

Dr. Tsai has been a member of the American Medical Association, American College of Physicians, American Society of Clinical Oncology. He has been the local principle investigator for various clinical trials and has presented at workshops and symposiums across the United States. He has authored a book chapter and manuscript related to cancer.

Clinical Study Details

  1. Accepting new patients
  2. study started August 2022
  3. Observational
  4. March 24, 2026
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