Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

ctDNA monitoring will be performed at protocol-specified intervals and requirement

Imaging examination will be performed at protocol-specified intervals and requirement

Patients who undergoing radical surgery for colorectal cancer for 6\~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled, and diagnostic laparoscopy will be performed immediately after enrollment. Patients with positive peritoneal metastasis (PCI score \<20) will be treated with CRS+HIPEC. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months in patients with negative peritoneal metastasis. Laparoscopy will be performed when imaging suggested peritoneal metastasis (oligometastases). Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.

ctDNA monitoring

Patients who undergoing radical surgery for colorectal cancer for 6\~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled. and there will be no need to conduct endoscopic exploration immediately after enrollment. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months until imaging suggested peritoneal metastasis (oligometastases). Patients with positive peritoneal metastasis (PCI score \<20) will be treated with CRS+HIPEC. Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.

Imageology

Hui Wang, MD, PhD

Tenghui Ma, MD, PhD

This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.

ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study

The survival rate without peritoneal metastasis (oligometastatic) at 24 months after radical resection of colorectal cancer.

DR of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.

DR of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

DR of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

Will be compared in both arms.

PPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.

PPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

PPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

Will be compared in both arms.

NPA of ctDNA monitoring for predicting peritoneal metastasis with abdominal exploration as the reference.

NPA of imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

NPA of combination of ctDNA monitoring and imageological examination for predicting peritoneal metastasis with abdominal exploration as the reference.

Will be compared in both arms.

This scale measures the extent of peritoneal cancer throughout the peritoneal cavity.

The range of this scale is from 0 to 39.

0 = no disease within the peritoneal cavity

0-9 = minimal disease

10-29 = moderate disease

30-39 = extensive disease

Lower values are considered a better outcome for the patient.

Will be compared in both arms.

The degree to which the disease was able to be excised during the procedure.

This scale ranges from CC0-CC3.

CC0 = all disease has been cleared, with no visible peritoneal carcinomatosis after CRS

CC1 = microscopic disease remains (Nodules persisting \< 2.5 mm after CRS)

CC2 = macroscopic disease remains (Nodules persisting between 2.5 mm and 2.5 cm)

CC3 = Substantial Macroscopic disease remains (Nodules persisting \> 2.5 cm)

Lower values are considered a better outcome, with CC0/1 classed as favourable and CC2/3 indicating an incomplete clearance of disease.

Will be compared in both arms.

Whether the patient is still alive and free of disease or not.

Will be compared in both arms.

Whether the patient is still alive or not.

Will be compared in both arms.

Sixth Affiliated Hospital, Sun Yat-sen University

Patients of ctDNA positive group receive individual adjuvant chemotherapy. The ctDNA status are evaluated every 2 months.

ctDNA and adjuvant therapy

Patients of ctDNA negative group are monitored by ctDNA every 3 months.

ctDNA

Junjie Peng

The goal of this clinical trial is to detect the prognostic value of longitudinal monitoring circulating tumor DNA (ctDNA) for no evidence of disease (NED) status in metastatic colorectal cancer (mCRC) patients and its utility in guiding therapeutic intervention. The main questions it aims to answer are:

1. Whether ctDNA monitoring could evaluate NED status ahead of normal radiologic monitoring. What about the concordance of evaluating NED status by ctDNA monitoring compared with normal radiologic monitoring?
2. Whether the patients with ctDNA positive status could benefit from early therapeutic intervention.

Patients who receive any kinds of therapies with the aim of NED and are confirmed by clinical and radiologic examination will go through longitudinal ctDNA monitoring. According to the results of ctDNA monitoring, the patients will be divided into ctDNA positive group and ctDNA negative group. Patients in ctDNA positive group will receive individual therapeutic plan decided by the investigator. Patients in ctDNA negative group will receive regular examinations. When radiologic recurrences are confirmed, the patients will be re-evaluated for a second opportunity of radical resection.

Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention

Predictive Value of Circulating Tumor DNA (ctDNA) for no Evidence of Disease (NED) Status in Metastatic Colorectal Cancer (mCRC) and Its Utility in Guiding Therapeutic Intervention: an Open-label, Prospective, Phase II Cohort Study

To detect the RFS time in metastatic colorectal cancer (mCRC) patients with no evidence of disease (NED) status who received circulating tumor DNA (ctDNA) guided therapies.

To detect the OS time in mCRC patients with NED status who received ctDNA guided therapies.

When the NED status is confirmed by radiology post-operation, it will also be assessed the ctDNA positive rate.

In this study, we aim to evaluate the NED status by ctDNA and traditional radiologic methods. The concordance index will be used to detect the identity of two methods.

When the diseases relapse during the follow-up. The multi-disciplinary treatment (MDT) team will discuss the opportunities to achieve a second NED status.

Guangzhou Burning Rock Dx Co., Ltd.

Fudan University

MD, PhD

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Fluorodeoxyglucose F18

FAPI-46

Radiopharmaceuticals

In the experimental arm, patients and their treating physician will be made aware of the molecular relapse (positive ctDNA detection results) in study steps 1 (ctDNA monitoring). To locate metastatic deposits, patients will be offered to undergo a whole-body imaging with 18F-FDG PET-CT and 68Ga-FAPI-46-PET-CT, in addition to any other workup considered as relevant by their treating physician.

In the control arm, patients and their treating physician will not be made aware of the molecular relapse and will continue the standard surveillance with repeated ctDNA test every 3 months (blinded). ). At the time of the clinical/radiological diagnosis of relapse, similar procedures will be performed (18F-FDG PET-CT, 68Ga-FAPI-46-PET-CT, and tumor genetic landscape assessment by ctDNA analysis).

For each patient included, a ctDNA detection assay will be performed in blood samples every 3 months, while extra-plasma will be banked. ctDNA results will be available with a turnaround time of less than 3 weeks. When negative, ctDNA detection results will not be disclosed to patients nor clinicians.

). To locate metastatic deposits, patients will be offered to undergo a whole-body imaging with 18F-FDG PET-CT and 68Ga-FAPI-46-PET-CT, in addition to any other workup considered as relevant by their treating physician.

68Ga-FAPI-46-PET-CT

Sandra B NESPOULOUS

Anne-Claire COYNE

Julien GRENIER

Monica ARNEDOS, MD

Marie-Ange MOURET-REYNIER

Marie-Ange MOURET-REYNIER, MD

Renaud SABATIER, MD

William JACOT, MD

Frédéric FITENI, MD

Louis TEXEIRA, MD

Joseph GLIGOROV

Thibault DE LA MOTTE ROUGE, MD

François-Clément BIDARD

François-Clément BIDARD, MD

Florence DALENC, MD

Florence DALENC

Vincent MASSARD, MD

CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse.

The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \~3 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.

The CUPCAKE trial will follow the Trials within Cohorts (TwiCs) approach. Non-metastatic TNBC patients at high risk of relapse will be included, after having signed a written informed consent, in a cohort allowing them to be followed by ctDNA monitoring every 3 months.

For each patient included, a ctDNA detection assay will be performed in blood samples every 3 months, while extra-plasma will be banked. ctDNA results will be available with a turnaround time of less than 3 weeks. When negative, ctDNA detection results will not be disclosed to patients nor clinicians.

First line therapy will not be started until a metastatic relapse has been found by imagining: no treatment will be started in the sole basis of a positive ctDNA test.

If, at any timepoint, ctDNA is detected (molecular relapse), patients will be randomized in a 1:1 ratio.

* In the experimental arm, patients and their treating physician will be made aware of the molecular relapse (positive ctDNA detection results). To locate metastatic deposits, patients will be offered to undergo a whole-body imaging with 18F-FDG PET-CT and 68Ga-FAPI-46-PET-CT, in addition to any other workup considered as relevant by their treating physician. If/when a clinical/radiological relapse is observed, the patient performance status will be registered (secondary objective) and systemic or local treatments will be decided by physicians. These treatments could be informed by the genetic landscape of the relapse, assessed by ctDNA.
* In the control arm, patients and their treating physician will not be made aware of the molecular relapse and will continue the standard surveillance with repeated ctDNA test every 3 months (blinded). At the time of the clinical/radiological diagnosis of relapse, similar procedures will be performed (18F-FDG PET-CT, 68Ga-FAPI-46-PET-CT, and tumor genetic landscape assessment by ctDNA analysis).

CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse.

68Ga-FAPI-46 is the radiopharmaceutical product. There is no study treatment (standard of Care).

Upon detection of ctDNA during Step1, patients will be centrally assigned to the control or the experimental arm (1:1) using the eCRF.

Randomization will be stratified by RCB score (I/II vs. III/NA because no neoadjuvant chemotherapy) and by time to molecular relapse (\< 12 months vs. ≥ 12 months between surgery and molecular relapse).

Early Detection of Triple Negative Breast Cancer Relapse

Early Detection of Triple Negative Breast Cancer Relapse: a Clinical Utility Phase II Trial

Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accrodance with Institut Curie policies.

OS rate for the main analysis (primary endpoint) is defined as the percentage of patients still alive 24 months after the randomization. If the patient is not present at the 24th month visit, survival data may be obtained by other means, such as telephone contact with the patient, his family, his current physician, or consulting local death registries.

A non-comparative analysis will be conducted in the experimental arm, and the control arm will serve as reference.

The number of metastatic sites upon clinical/radiological relapse will be defined post-hoc by the Adjudication Committee as the number of organs or systems in which metastases are detected at the time of the clinical/radiological relapse, among the following propositions: lymph nodes, bones, liver, lungs, central nervous system/meninges, peritoneum, others.

RFS \[recurrence-free survival\], defined as the time from randomization to clinical/radiological relapse or death; PFS \[progression-free survival\], defined as the time from randomization to the first progression or death occurring after clinical/radiological relapse; 1L-PFS \[first line PFS\], defined as the time from clinical/radiological relapse to first progression or death ; 2L-PFS \[second line PFS\], defined as the time from first to second progression or death; progression being defined per RECIST criteria.

Best ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST 1.1, until first progression or last tumor assessment in the absence of progression. ORR will be reported with its 95% confidence interval by arm.

Overall Survival is defined as the time between randomization and death.

Proportion of patients presenting with an altered general condition (PS ≥2) at first evidence of clinical or radiological relapse.

The population of interest consists in randomized patients.

The EORTC-QLQ-C30 questionnaire with the QLQ-BR45 is used to report health-related QoL in all included patients. Summary statistics of the scores for all functional/symptom scales will be calculated at each assessment time point, according to the scoring procedure recommended by the EORTC.

All of the scales and single item measures range in score from 0 to 100. A high score for the functional scales and functional single items represents a high/healthy level of functioning, whereas a high score for the symptom scales and symptom item represents a high level of symptomatology or problems.

y. Each state is referred to in terms of a 5 digit code. For example, state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with doing usual activities, severe pain or discomfort and extreme anxiety or depression. A completely healthy patient would have a score of 11111. This 5-digit number can be converted into a score using a special algorithm that is not publicly available. This point value is called the EQ-5D-5L Index and represents the patient's health status.

National Research Agency, France

Roche Pharma AG

Institut Curie

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

For patients with negative ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks.

For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks.

For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after 3 cycles of TKI plus chemotherapy.

For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after 3 cycles of sequential neoadjuvant PD-1 blockades plus chemotherapy.

Patients will receive ctDNA monitoring before and after 3 weeks of neoadjuvant 3rd TKI treatment and optimize the neoadjuvant treatment plan based on this.

Xuqi Sun, MD

Weijia Fang, MD

This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients.

This study aimed to prospectively enroll approximately 300 resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC patients with histologically confirmed EGFR 19del or L858R mutations. Peripheral blood samples will be collected at baseline before neoadjuvant 3rd-generationEGFR TKI therapy, and ctDNA levels will be quantitatively assessed. For patients with positive baseline ctDNA, peripheral blood will be collected again after 3 weeks of neoadjuvant TKI therapy to assess if ctDNA has turned negative, and HRCT will be performed to evaluate the treatment efficiency simultaneously.

In patients with positive baseline ctDNA, for ctDNA-negative patients after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks (Group A). For ctDNA-positive patients after 3 weeks of neoadjuvant TKI treatment, in combination with imaging changes in the lesions, a multidisciplinary team (MDT) evaluation will be conducted. After discussion between the attending physicians and the patient, the subsequent treatment will either continue TKI treatment for 9-12 weeks (Group B), undergo 3 cycles of TKI plus chemotherapy (Group C), or undergo sequential neoadjuvant immunotherapy plus chemotherapy for 3 cycles (Group D) before radical resection surgery.The study intends to evaluate the correlation between the rate of major pathological response (MPR) and ctDNA levels at 3 weeks after TKI treatment, to compare the difference in pathological response between ctDNA-negative and ctDNA-positive groups after 3 weeks of neoadjuvant TKI treatment and to evaluate the guiding value of dynamic ctDNA monitoring during neoadjuvant therapy for optimizing subsequent treatments.

The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC

the proportion of patients who achieve MRP among those receiving pneumonectomy

the proportion of patients who achieve pCR among those receiving pneumonectomy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer	NCT04752930	Colorectal Canc... Peritoneal Meta...	ctDNA monitorin... Imageology	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University
Predictive Value of ctDNA for NED Status in mCRC and Its Utility in Guiding Therapeutic Intervention	NCT05635630	Metastatic Colo... No Evidence of ... ctDNA Monitorin...	ctDNA and adjuv... ctDNA	18 Years - 85 Years	Fudan University
Early Detection of Triple Negative Breast Cancer Relapse	NCT06225505	Triple Negative...	ctDNA monitorin... 68Ga-FAPI-46-PE...	18 Years -	Institut Curie
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC	NCT06287593	EGF-R Positive ...	ctDNA monitorin...	18 Years - 75 Years	Zhejiang University
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer	NCT04752930	Colorectal Canc... Peritoneal Meta...	ctDNA monitorin... Imageology	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University

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