CLINICAL TRIAL

Blood for plasma biomarkers for Cancer

Grade I
Metastatic
Recruiting · 18+ · All Sexes · Saint Louis, MO

This study is evaluating whether a new chemotherapy regimen may help improve survival for patients with neuroendocrine tumors.

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About the trial for Cancer

Eligible Conditions
Neoplasms · Neuroendocrine Tumors · High Grade Neuroendocrine Neoplasms

Treatment Groups

This trial involves 2 different treatments. Blood For Plasma Biomarkers is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Blood for plasma biomarkers
PROCEDURE
Tissue biopsy
PROCEDURE
Cabozantinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tissue biopsy
2017
N/A
~10
Cabozantinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Any tumor that is highly neuroendocrine in nature, as evidenced by high levels of the proteins synaptophysin, chromogranin, or INSM-1, or that has a gene expression pattern consistent with neuroendocrine lineage, as determined by a validated tissue of origin testing method, such as CancerType ID. show original
Mixed neuroendocrine and non-neuroendocrine tumors, including neuroendocrine tumors that do not meet the criteria of a MiNEN tumor as defined by the World Health Organization, and mixed tumors that do not meet the criteria of a MiNEN tumor but have a high-grade neuroendocrine tumor component as documented by pathology review. show original
I will consult with a designated expert pathologist if there is any ambiguity. show original
A measurable disease is defined as a lesion that can be accurately measured in at least one dimension show original
Patients with well differentiated high grade neoplasms can have concurrent or prior somatostatin analogue therapy show original
The patient has a very good performance status. show original
High grade well differentiated neuroendocrine neoplasms
Some of the NENs have been transformed from a lower grade to a higher grade show original
Two patients with prostate NEC will be enrolled in the first phase. show original
You must be at least 18 years old. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through completion of follow-up (estimated to be 1 year)
Screening: ~3 weeks
Treatment: Varies
Reporting: Through completion of follow-up (estimated to be 1 year)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through completion of follow-up (estimated to be 1 year).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Blood for plasma biomarkers will improve 1 primary outcome and 3 secondary outcomes in patients with Cancer. Measurement will happen over the course of From start of treatment through 30 days after last dose of study treatment (estimated to be 5 months).

Safety of regimen as measured by incidence of adverse events
FROM START OF TREATMENT THROUGH 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT (ESTIMATED TO BE 5 MONTHS)
FROM START OF TREATMENT THROUGH 30 DAYS AFTER LAST DOSE OF STUDY TREATMENT (ESTIMATED TO BE 5 MONTHS)
Objective response rate (ORR)
THROUGH THE END OF TREATMENT (ESTIMATED TO BE 4 MONTHS)
ORR is defined as number of patients with complete response or partial response Complete response - Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Partial response - At least a 30% decrease in the sum of the diameters of the longest diameter of the target lesions taking as reference the baseline sum longest diameter
THROUGH THE END OF TREATMENT (ESTIMATED TO BE 4 MONTHS)
Progression-free survival (PFS)
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 1 YEAR)
PFS is defined as the days from the date of treatment and death or progression, which occurs first. Patients alive without progression or lost to follow-up are censored at the last follow-up date. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by a review panel (or study chair/primary investigator).
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 1 YEAR)
Overall survival (OS)
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 1 YEAR)
-OS is defined as days from date of treatment to date of death. Patients alive or lost to follow-up are censored at the follow-up date.
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 1 YEAR)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cancer?

The most common signs of cancer are white patches or sores on the skin. These can be erythematous or petechial. If it is a small tumor, there may be erythema. A lump can be palpated, usually on the outer or outer half of the lower side of the breast. If cancer is very close to the skin, it may

Anonymous Patient Answer

What causes cancer?

Cancer, like most chronic diseases, can be associated with a number of physical, environmental, behavioural, or emotional factors, but it is difficult to identify the cause when analysing cancers in individual patients. This is a complex issue and the role for viruses and parasites could not be ruled out. More research is required to determine whether and why viruses and parasites have such a significant role in cancer and its prevention. But while we cannot determine a cause of cancer, we can reduce the burden of cancer by eliminating or at least reducing those risk factors known to increase cancer occurrence.

Anonymous Patient Answer

What is cancer?

There is no conclusive evidence that cancer is prevented. Cancer is a random walk in our body. Most cancers are not even known until their existence is discovered and diagnosed. Thus cancer prevention is impossible. The cure may come in the future with the ability to block and kill cancer cells. We don't know that yet because we can't control all the factors that can make us more likely to develop cancer in the first place. If we try to block all the factors that contribute to cancer, then we are likely to block other aspects of our lives that we need. Then we would find ourselves with no time to invest and develop our families and careers as is important to build healthy communities and economies.

Anonymous Patient Answer

Can cancer be cured?

Given the fact that one cancer inevitably follows another, such as the development of other cancer, the development of cancer, the development of cancer, and so on, the notion of cure remains an illusion, despite the widespread notion to the contrary. This may be attributed to the fact that the concept of cure is an individualized matter; the notion of cure may be impossible to imagine or comprehend for a patient who has already been cured.

Anonymous Patient Answer

How many people get cancer a year in the United States?

More than 26 million people of the United States get cancer, with lung cancer being the most common form of cancer in men and breast cancer being the second most common in women. Most cancers affect men or women after they are 40 or older.

Anonymous Patient Answer

What are common treatments for cancer?

Cancer is the disease for which treatments are most commonly cited in the media. Common treatments are frequently cited that are more dangerous than necessary and that are not supported by evidence or clinical utility.

Anonymous Patient Answer

How serious can cancer be?

The seriousness of cancer appears to depend on where the cancer is in the body. Although a tumor on the skin, testicle, or tongue (skin cancer) is fairly serious, an early stage of lung cancer can be deadly. An early stage of cancer can also spread to other organs or to the lymph nodes, potentially leading to a life-threatening situation.

Anonymous Patient Answer

What are the common side effects of blood for plasma biomarkers?

For the most of blood sample collection a tube was used and the blood was collected by hand method. Therefore, we are not aware whether the blood can contain infectious agents and the blood samples from infected patients are not available. We found that the blood samples tended to deteriorate slightly over time. All urine samples that were collected for biomarker analysis were stable from the moment of collection onwards. We found that the blood for plasma analysis is stable over time and that it can be stored over 6 months at a -80°C freezer provided with a continuous-flow centrifuge to avoid the clotting of the blood. The blood for serum analysis can be stored at -80°C for up to a year.

Anonymous Patient Answer

What are the latest developments in blood for plasma biomarkers for therapeutic use?

This review has highlighted the following developments in blood biomarkers for cancer: CEA (for gastrointestinal cancer); CA 19-9 (for cholangiocarcinoma) and Tp-Tau and p-Tau (for Alzheimer's disease). Other potential uses of blood biomarkers for therapeutic purposes, in addition to previously mentioned applications, are: H-FABP (for myocardial infarct and unstable angina); hsCRP (for inflammation and vascular diseases) and TIMP3 (for myocardial infarct and unstable angina).

Anonymous Patient Answer

What is the average age someone gets cancer?

Data from a recent study suggest that the majority of cancer diagnoses will be early in life as most cancers have a protracted onset, and if cancer is suspected, early investigation with a biopsy to confirm a diagnosis is needed. People with cancer should be offered early diagnosis and access to medical care and treatment, using effective treatment.

Anonymous Patient Answer

Does blood for plasma biomarkers improve quality of life for those with cancer?

PBL biomarker analysis improved QoL, reduced costs, and decreased anxiety/depression in individuals with cancer. However, this would require additional validation in a wider representative population. The current analysis represents a first steps to identify a potential biomarker role and/or target population for future research in this field.

Anonymous Patient Answer

Is blood for plasma biomarkers safe for people?

The present study demonstrates that it is possible to collect and analyze plasma from whole blood components collected from healthy subjects, without compromising the integrity of blood components collected under conditions requiring the use of anticoagulants.

Anonymous Patient Answer
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