Appendix Carcinoma by AJCC V8 StageNCT04929015
Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)
A study testing Biospecimen Collection - blood and tissue sample collection and Electronic Health Record Review in people with Appendix Carcinoma by AJCC V8 Stage and Colorectal Carcinoma by AJCC V8 Stage, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendix Carcinoma by AJCC V8 Stage, Colorectal Carcinoma by AJCC V8 Stage, Digestive System Neoplasm
- What is being tested?
- Biospecimen Collection - blood and tissue sample collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2021to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed carcinoma of presumed gastrointestinal origin (gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal carcinomatosis of apparent GI primary) with documented diffuse peritoneal carcinomatosis, either by conventional imaging studies, positive ascitic fluid analysis, or surgical staging
- Measurable or evaluable disease by cross-sectional imaging studies
- Patients must be candidates for possible surgical cytoreduction (with or without HIPEC) as determined by a study surgical oncologist
- Age >= 18 years
- Estimated life expectancy of at least 12 months
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
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- Patients must sign informed consent
- Be willing to present for medical exams, blood draws and imaging as scheduled in protocol
- Be able to donate two 10 mL tubes of blood every 3 months
- Women of childbearing potential will undergo routine screening evaluation for pregnancy prior to enrollment and be managed per standard of care
Who cannot join
- Patients without a confirmed pathologic diagnosis of carcinoma
- Second uncontrolled primary malignancy
- Patients who are pregnant
- Patients who cannot undergo a therapeutic surgical cytoreduction
- Bone marrow transplant or other organ transplant recipient
- Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
- Patients with cardiovascular or pulmonary risk factors contributing to high risk for surgical complications, at the discretion of the surgeon
- Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
RWJBarnabas Health - Cooperman Barnabas, Livingston
Livingston, New Jersey, 07039
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Everyone is born with the same DNA in all our cells throughout our body. Sometimes, some of the cells in the body develop abnormalities in the DNA that cause those cells to grow abnormally and uncontrollably. Cancer occurs when there is abnormal and uncontrolled growth of cells. The DNA in cancer cells is therefore different from the DNA someone is born with. The Signatera ctDNA assay is a laboratory test that takes tumor (cancer) tissue and evaluates it for unique tumor DNA. This evaluation is used to create a report (otherwise known as an assay) personalized to each person's cancer. The personalized assay creates a personalized blood test to detect the level of abnormal DNA from the cancer that may be circulating in the body. Once this personalized blood assay is designed, it may be used to monitor a person's blood for the presence of ctDNA, which will indicate the presence or absence of cancer over time, even after treatment.
Read the detailed description
This study is an exploratory analysis of the utility of ctDNA as a sensitive biomarker in patients with Peritoneal Carcinomatosis treated with chemotherapy, CRS and/or hyperthermic intraperitoneal chemotherapy (HIPEC).
OBJECTIVES:
- To measure changes in circulating tumor deoxyribonucleic acid (ctDNA) in patients with peritoneal carcinomatosis (PC) from gastrointestinal (GI) cancers who are candidates for cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC).
II. To determine the percentage of patients on protocol with undetectable ctDNA (clearance rate) after complete CRS.
III. To identify any associations between clinical staging of CRS and measurable ctDNA.
IV. To assess changes in ctDNA levels in response to chemotherapy in patients with PC.
- To guide treatment based on ctDNA response.
OUTLINE:
Patients may receive induction chemotherapy at the discretion of the treating physician for up to 6 months. Patients undergo blood sample collection for ctDNA analysis at baseline, post chemotherapy/pre-surgery, 3-4 weeks post CRS/HIPEC, then every 3 months over 2 years. Patients also undergo tissue collection before or during surgery and their medical records are reviewed.
- Conditions
- Appendix Carcinoma by AJCC V8 Stage, Colorectal Carcinoma by AJCC V8 Stage, Digestive System Neoplasm, Esophageal Carcinoma by AJCC V8 Stage, Gastric Carcinoma by AJCC V8 Stage, Liver and Intrahepatic Bile Duct Carcinoma
- Being tested
- Biospecimen Collection - blood and tissue sample collection, Electronic Health Record Review
- Medical subject headings
- Digestive System Neoplasms, Carcinoma, Hepatocellular, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen Collection - blood and tissue sample collectionProcedure or surgery
The original tissue sample from each patient will be obtained at time of surgery or prior to surgery. Plasma for ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up 2 years
Electronic Health Record ReviewOther
Medical record reviewed
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (biospecimen collection) | Experimental | Patients will receive standard treatment with surgery, HIPEC, and chemotherapy as appropriate to the patient situation, extent of disease and multi-disciplinary evaluation.
Patients undergo blood sample collection for ctDNA analysis at baseline, pre-surgery, post-surgery and every 3 months up to 2 years.
Patients undergo tissue collection before or during surgery and their medical records are reviewed. Receives: Procedure: Biospecimen Collection - blood and tissue sample collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)
Will compare results with clinical staging of CRS (surgical staging, surgical outcomes, Peritoneal Carcinoma Index [PCI] and cytoreduction [CC] score). ctDNA clearance rate defined as the % of patients on our protocol with undetectable ctDNA. Will associate ctDNA changes with clinical response by Response Evaluation Criteria in Solid Tumors and surgical staging, surgical outcomes, PCI and CC score using standard T-testing, log-rank analysis or similar non-parametric testing.
Measured: Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Correlation of ctDNA clearance with activity of chemotherapy
Will correlate ctDNA clearance with activity of chemotherapy in this disease pre-op and post-op
Measured: Baseline, pre-surgery, 3-4 weekd post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Secondary outcomes (5)
Positivity rate of ctDNA in patients with peritoneal carcinomatosis
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
Measured: Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.
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
Measured: Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CEA levels and ctDNA levels
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
Measured: Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CA19.9 levels and ctDNA levels
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
Measured: 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
ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up to 2 years
Measured: Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start29 Apr 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Why it stopped: Pending Protocol amendment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendix Carcinoma by AJCC V8 StageStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Henry Richard Alexander, MD, Rutgers, The State University of New Jersey
- Investigators
- Henry R Alexander, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929015
- Sponsor's protocol ID
- Pro2021000017
- Other IDs
- 072013, P30CA072720, NCI-2021-02123
- Status last verified
- Apr 2026
- First submitted
- 31 May 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Carcinomatosis Leveraging ctDNA Guided Treatment in GI Cancer Study (PERICLES Study)
- ClinicalTrials.gov ID
- NCT04929015
- Acronym / sponsor ID
- Pro2021000017
- Conditions
- Appendix Carcinoma by AJCC V8 Stage, Colorectal Carcinoma by AJCC V8 Stage, Digestive System Neoplasm, Esophageal Carcinoma by AJCC V8 Stage, Gastric Carcinoma by AJCC V8 Stage, Liver and Intrahepatic Bile Duct Carcinoma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pending Protocol amendment
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial collects biospecimen samples to create a personalized ctDNA test to guide treatment for patients with gastrointestinal cancer with peritoneal carcinomatosis. Deoxyribonucleic acid, or DNA, is the material that carries all the information about how a living thing will work and function. Everyone is born with the same DNA in all our cells throughout our body. Sometimes, some of the cells in the body develop abnormalities in the DNA that cause those cells to grow abnormally and uncontrollably. Cancer occurs when there is abnormal and uncontrolled growth of cells. The DNA in cancer cells is therefore different from the DNA someone is born with. The Signatera ctDNA assay is a laboratory test that takes tumor (cancer) tissue and evaluates it for unique tumor DNA. This evaluation is used to create a report (otherwise known as an assay) personalized to each person's cancer. The personalized assay creates a personalized blood test to detect the level of abnormal DNA from the cancer that may be circulating in the body. Once this personalized blood assay is designed, it may be used to monitor a person's blood for the presence of ctDNA, which will indicate the presence or absence of cancer over time, even after treatment.
Detailed description
This study is an exploratory analysis of the utility of ctDNA as a sensitive biomarker in patients with Peritoneal Carcinomatosis treated with chemotherapy, CRS and/or hyperthermic intraperitoneal chemotherapy (HIPEC).
OBJECTIVES:
- To measure changes in circulating tumor deoxyribonucleic acid (ctDNA) in patients with peritoneal carcinomatosis (PC) from gastrointestinal (GI) cancers who are candidates for cytoreductive surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC).
II. To determine the percentage of patients on protocol with undetectable ctDNA (clearance rate) after complete CRS.
III. To identify any associations between clinical staging of CRS and measurable ctDNA.
IV. To assess changes in ctDNA levels in response to chemotherapy in patients with PC.
- To guide treatment based on ctDNA response.
OUTLINE:
Patients may receive induction chemotherapy at the discretion of the treating physician for up to 6 months. Patients undergo blood sample collection for ctDNA analysis at baseline, post chemotherapy/pre-surgery, 3-4 weeks post CRS/HIPEC, then every 3 months over 2 years. Patients also undergo tissue collection before or during surgery and their medical records are reviewed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (biospecimen collection) | Experimental | Procedure: Biospecimen Collection - blood and tissue sample collection, Other: Electronic Health Record ReviewPatients will receive standard treatment with surgery, HIPEC, and chemotherapy as appropriate to the patient situation, extent of disease and multi-disciplinary evaluation. Patients undergo blood sample collection for ctDNA analysis at baseline, pre-surgery, post-surgery and every 3 months up to 2 years. Patients undergo tissue collection before or during surgery and their medical records are reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed carcinoma of presumed gastrointestinal origin (gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal carcinomatosis of apparent GI primary) with documented diffuse peritoneal carcinomatosis, either by conventional imaging studies, positive ascitic fluid analysis, or surgical staging
- Measurable or evaluable disease by cross-sectional imaging studies
- Patients must be candidates for possible surgical cytoreduction (with or without HIPEC) as determined by a study surgical oncologist
- Age >= 18 years
- Estimated life expectancy of at least 12 months
Key exclusion criteria (8 listed)
- Patients without a confirmed pathologic diagnosis of carcinoma
- Second uncontrolled primary malignancy
- Patients who are pregnant
- Patients who cannot undergo a therapeutic surgical cytoreduction
- Bone marrow transplant or other organ transplant recipient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen Collection - blood and tissue sample collectionThe original tissue sample from each patient will be obtained at time of surgery or prior to surgery. Plasma for ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up 2 years | Procedure or surgery | Diagnostic (biospecimen collection) |
| Electronic Health Record ReviewMedical record reviewed | Other | Diagnostic (biospecimen collection) |
Primary outcome
Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS)
Time frame: Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Will compare results with clinical staging of CRS (surgical staging, surgical outcomes, Peritoneal Carcinoma Index [PCI] and cytoreduction [CC] score). ctDNA clearance rate defined as the % of patients on our protocol with undetectable ctDNA. Will associate ctDNA changes with clinical response by Response Evaluation Criteria in Solid Tumors and surgical staging, surgical outcomes, PCI and CC score using standard T-testing, log-rank analysis or similar non-parametric testing.
Correlation of ctDNA clearance with activity of chemotherapy
Time frame: 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
5 secondary outcomes
Positivity rate of ctDNA in patients with peritoneal carcinomatosis
Time frame: Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
ctDNA and its association with results of next generation sequence (NSG) analysis from original tumor tissue.
Time frame: Baseline, pre-surgery, 3-4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CEA levels and ctDNA levels
Time frame: Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)
Associations between CA19.9 levels and ctDNA levels
Time frame: 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
Time frame: Baseline, pre-surgery, 3-4 weeks post-surgery and every 3 months up to 2 years after cytoreductive surgery (CRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Appendix Carcinoma by AJCC V8 Stage
RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma
RecruitingPhase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry R Alexander, MD principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection - blood and tissue sample collection and Electronic Health Record Review in people with Appendix Carcinoma by AJCC V8 Stage and Colorectal Carcinoma by AJCC V8 Stage, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance rate of circulating tumor deoxyribonucleic acid (ctDNA) with cytoreductive surgery (CRS) (time frame: Baseline, pre-surgery, 3- 4 weeks post-surgery and then every 3 months up to 2 years after cytoreductive surgery (CRS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.