Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Overview

About this study

The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Eligibility last updated 10/27/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Mankato, Minn.

Mayo Clinic principal investigator

Amrit Singh, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Mina Hanna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20541353

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