CLINICAL TRIAL

Biospecimen Collection - blood and tissue sample collection for Carcinoma

Waitlist Available · 18+ · All Sexes · New Brunswick, NJ

This study is evaluating whether a personalized ctDNA test can be used to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis.

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About the trial for Carcinoma

Eligible Conditions
Peritoneal Carcinomatosis · Liver and Intrahepatic Bile Duct Carcinoma · Carcinoma · Digestive System Neoplasms · Gastric Carcinoma by AJCC V8 Stage · Gastrointestinal Neoplasms · Esophageal Carcinoma by AJCC V8 Stage · Peritoneal Neoplasms · Colorectal Neoplasms · Stomach Neoplasms · Esophageal Neoplasms · Appendix Carcinoma by AJCC V8 Stage · Colorectal Carcinoma by AJCC V8 Stage

Treatment Groups

This trial involves 2 different treatments. Biospecimen Collection - Blood And Tissue Sample Collection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Electronic Health Record Review
OTHER
Biospecimen Collection - blood and tissue sample collection
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

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:
Candidates for surgery must be determined by a study surgical oncologist. show original
Age >= 18 years
The text states that the person's life expectancy is at least 12 months. show original
The individual has a performance status of 2 or less as determined by the Eastern Cooperative Oncology Group. show original
Women who could potentially get pregnant will have a routine screening to test for pregnancy before they enroll in the study, and they will be managed according to standard of care. show original
Be willing to go to any appointment with the study staff Be available for contact by phone or email Be willing to keep study-related appointments The subject must be willing to attend all study appointments, present for medical exams and blood draws, and be available for contact by phone or email. show original
Be able to donate two 10 mL tubes of blood every 3 months
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS).
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 Biospecimen Collection - blood and tissue sample collection will improve 2 primary outcomes and 5 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS).

Associations between CA125 levels and ctDNA levels
BASELINE, PRE-SURGERY, 3-4 WEEKS POST-SURGERY AND EVERY 3 MONTHS UP TO 2 YEARS AFTER CYTOREDUCTIVE SURGERY (CRS)
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
Associations between CA19.9 levels and ctDNA levels
BASELINE, PRE-SURGERY, 3-4 WEEKS POST-SURGERY AND EVERY 3 MONTHS UP TO 2 YEARS AFTER CYTOREDUCTIVE SURGERY (CRS)
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.
BASELINE, PRE-SURGERY, 3-4 WEEKS POST-SURGERY AND THEN EVERY 3 MONTHS UP TO 2 YEARS AFTER CYTOREDUCTIVE SURGERY (CRS)
ctDNA will be obtained at baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years. ctDNA from blood samples will be compared with the results of NSG analysis from original tumor tissue
Positivity rate of ctDNA in patients with peritoneal carcinomatosis
BASELINE, PRE-SURGERY, 3-4 WEEKS POST-SURGERY AND THEN EVERY 3 MONTHS UP TO 2 YEARS AFTER CYTOREDUCTIVE SURGERY (CRS)
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
Correlation of ctDNA clearance with activity of chemotherapy
BASELINE, PRE-SURGERY, 3-4 WEEKD POST-SURGERY AND THEN EVERY 3 MONTHS UP TO 2 YEARS AFTER CYTOREDUCTIVE SURGERY (CRS)
Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op
Associations between CEA levels and ctDNA levels
BASELINE, PRE-SURGERY, 3-4 WEEKS POST-SURGERY AND EVERY 3 MONTHS UP TO 2 YEARS AFTER CYTOREDUCTIVE SURGERY (CRS)
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
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Who is running the study

Principal Investigator
H. R. A.
Henry Richard Alexander, MD
Rutgers, The State University of New Jersey

Patient Q & A Section

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

Have there been other clinical trials involving biospecimen collection - blood and tissue sample collection?

The collection of biospecimens has an important role for the advancement of medical science and its application in personalized medicine. We present two clinical trials where a biospecimen collection was used to advance the field of OBCS. These studies provide evidence that biospecimen collections could be utilized to further our understanding of the pathophysiology of certain diseases.

Anonymous Patient Answer

Does carcinoma run in families?

Carcinoma has been found to be associated with some hereditary conditions, but this association is often weak. A family history of carcinoma does not predict the occurrence of carcinoma, and when present does not seem to modify the age at onset. [Power(http://www.withpower.com/clinical-trials/carcinoma)]: We want to know if familial cancers have different features compared to sporadic cancers. We want to find out why cancer occurs so frequently in relatives of patients with cancer.

Anonymous Patient Answer

What is the primary cause of carcinoma?

Diseases caused by smoking have been recognized since 1872.. Chronic infections such as hepatitis B virus, hepatitis C virus, and human immunodeficiency virus, as well as environmental factors such as diet, physical activity, and alcohol use, may increase the risk for developing certain types of cancers. Tobacco smoke increases the risk of lung cancer, squamous cell carcinoma of the head and neck, prostate cancer, bladder cancer, colorectal cancer, pancreatic cancer, and esophageal cancer.

Anonymous Patient Answer

What is carcinoma?

The International Agency for Research on Cancer (IARC) states that carcinoma is cancer of epithelial cells and are classified into 3 types based on their origin:\n\n1. Squamous cell carcinoma - originating from epithelial cells of squamous tissue.\n2. Adenocarcinoma - originating from glandular epithelium in organ ducts.\n3. Carcinoid tumours - originating from neuroendocrine cells in glands or from other tissues.

Anonymous Patient Answer

What is the survival rate for carcinoma?

The survival rate for carcinoma depends on several factors, such as stage at diagnosis, histological type, and presence of metastases. Survival rates vary depending on the primary site of origin and the subtype. The 5-year survival rate for carcinoma is approximately 80%. Teaching of medical students about carcinoma is important for them to understand how the survival rate varies and how these factors influence survival.

Anonymous Patient Answer

How does biospecimen collection - blood and tissue sample collection work?

Biospecimen collection may be affected by multiple factors including patient characteristics, type of biopsy specimen collected, and time interval between initiation of collection and receipt of the specimen at the laboratory.

Anonymous Patient Answer

What are the latest developments in biospecimen collection - blood and tissue sample collection for therapeutic use?

The majority of studies on biospecimen collections have been focused mainly on blood and related specimens and have primarily service medical applications. The number of studies investigating samples collected from other sites is increasing, particularly during the last decade, and is expected to continue. Most studies focus on whole-blood samples, serum or plasma, although some research has been conducted on cell-free nucleic acids, which are a key component of many biological fluids. The need for further development of the field remains evident.

Anonymous Patient Answer

What are the chances of developing carcinoma?

The chances of developing carcinoma upon stopping DHT are low, especially among men who were younger than 30 years at baseline. Carcinoma is much more likely to occur in women than in men after starting DHT.

Anonymous Patient Answer

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

Carcinoma is the second-most common cause of death among women aged 65 and older in the US. It accounts for approximately 8% (1,813,000) of all deaths in this age group.

Anonymous Patient Answer

Has biospecimen collection - blood and tissue sample collection proven to be more effective than a placebo?

Biospecimen collections are effective in identifying participants with PBC and in aiding in the characterization of histologic subtypes. Participants who had undergone biopsy (PBC-only) were more likely to be diagnosed at an earlier stage than those receiving just blood sampling.

Anonymous Patient Answer

What causes carcinoma?

The most common hypotheses explaining cancer are the genetic defect hypothesis and the environmental hypothesis. But we cannot be sure about the real cause of over 90% of all cancers because we have so little knowledge about this topic. In fact, we still don't know what causes cancer. So we need to focus our research on this problem. We will continue to ask questions like 'what causes cancer' and 'what helps people stay healthy'. The answer to these questions may eventually lead us to discover something useful for preventing cancer. Clinicians should remember to examine their patients with caution, because although the majority of cancers occur when a person is middle aged or older, many cancers (e.g., lung cancer) occur at young ages.

Anonymous Patient Answer
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