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Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow

Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers and Subjects Undergoing Lung Cancer Screening

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for cancer cells and DNA in blood, urine, and bone marrow, the soft tissue inside bones. The goal is to learn how cancer spreads and help improve future cancer screening and treatment. It includes adults with certain cancers, adults having surgery for noncancer reasons, and adults who qualify for lung cancer screening.

Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage. Circulating and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies and improve screening.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be older than 18. People of all genders and ethnic backgrounds may join.
  • The cancer group includes any stage of lung, esophageal (food pipe), stomach, bile duct, pancreatic, or colorectal cancer, melanoma, or sarcoma.
  • The comparison group includes people having surgery for noncancer reasons who have no suspected or past cancer, except basal cell skin cancer.
  • For cancer surgery patients, a biopsy (a tissue sample checked for cancer) is preferred. People whose scans and medical findings strongly suggest cancer may also join.
  • No extra biopsies, tests, or procedures will be done just for this study unless needed for medical care.
  • You must be able to understand the study and agree to join.
  • For the lung screening group, you must be age 55–80, currently smoke or have quit within 15 years, and have smoked more than 30 pack-years. One pack-year means smoking one pack a day for one year.

Who can't join

  • You cannot join if you are pregnant.
  • You cannot join if you have another active cancer at the same time, other than basal cell skin cancer, and there is evidence of that cancer or you are receiving chemotherapy.
  • You cannot join if your hemoglobin, a protein in red blood cells, is below 8 g/dL on the morning of the procedure.
  • If you need more than 4 units of red blood cells during surgery, no more study blood samples will be taken during surgery or the next day.
  • No bone marrow sample will be taken if you have a bleeding disorder that requires treatment to prevent serious bleeding. Examples include hemophilia or very low platelets, which are blood cells that help stop bleeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Subjects older than 18 years. * Subjects of all genders and ethnicities. * Subjects with the diagnosis of a solid cancer (n=100) of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma). * Ten patients with no present suspicion and no previous history of any cancer (except basal cell cancer of the skin) that undergo surgeries for other benign indications will serve as controls (n=10). * In patients undergoing surgery for cancer the histopathology should preferably be pathologically proven by a previous or novel biopsy. Yet, patients with a high cancer suspicion by radiology and clinical picture that undergo cancer surgery will not be excluded. No additional biopsies, testing or interventions will be performed for the purpose of this study if the medical treatment will not require it. * Subjects must be capable of giving informed consent. * Lung cancer screening eligibility criteria (n=100): 55-80 years old, \>30 pack years smoking history, and current smoker or have quit within the last 15 years) Exclusion Criteria: * Pregnant women. * Subjects with the concurrent diagnosis of an active secondary (synchronous) malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or if the patient is currently being treated with chemotherapy. * Subjects with a hemoglobin of \<8g/dl in the morning of the procedure will be excluded. * In subjects who require intraoperative transfusions of \>4 units of red packed blood cells (RPBCs), no further blood will be drawn for CTC/DTC/cfDNA analysis during surgery or on postoperative day 1. * In patients with coagulation disorders that could lead to significant bleeding (such as hemophilia, significant thrombocytopenia) requiring prophylactic administration of coagulative products, no bone marrow aspiration will be performed.

Study sites (1)

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