IMPROVE-IT2: Can individualized follow-up with knowledge from blood tests increase survival for colorectal cancer patients?
Over the last ten years, researchers have gained significant insight into how circulating tumor DNA (ctDNA) from blood tests can be used in cancer follow-up: Studies suggest that by measuring the amount and type of ctDNA in the blood of patients who have completed their treatment, early detection of relapses can be achieved, thereby improving survival for various forms of cancer.
In the IMPROVE-IT2 study, the applicants aim to determine whether ctDNA as a biomarker can also improve the detection of relapses in patients with stage III colorectal cancer (CRC III).
Currently, these patients follow a standardized follow-up program, which includes CT scans 12 and 36 months after the surgery. However, since 75 percent are cured following the surgery, the resources can be considered 'wasted' on the majority of the patients, while the survival rate is low for the remaining 25 percent. This is due to the fact that in most cases, the relapse is detected too late to offer curative treatment.
CC supports the implementation of the national, randomized intervention study IMPROVE-IT2, in which survival and costs of individualized ctDNA-based follow-up are compared with the current follow-up program for CRC III patients.
Project Name: IMPROVE-IT2: Implementing non-invasive circulating tumor DNA analysis to optimize the operative and postoperative treatment for patients with colorectal cancer – Intervention Trial 2 IBS
Principal Applicant: Professor Claus Lindbjerg Andersen, Department of Molecular Medicine (MOMA), Aarhus University Hospital and Aarhus University, on behalf of the IMPROVE-IT2 study group.
Amount: 500,000 DKK
Can artificial intelligence improve the quality of life for women who have undergone breast cancer surgery?
Every year, 3,500 women in Denmark undergo breast-conserving surgery. The purpose of the treatment, which often includes radiation therapy in addition to surgery, is to control the disease while preserving the breast with a good cosmetic result.
In clinical trials, a cosmetic outcome assessment (CO) is performed using a 4-point scale. This involves comparing the treated breast with the other breast. It turns out that patients with the two lowest scores in CO (respectively 'fair' and 'poor') often have a lower body self-assessment, find themselves less sexually attractive, and generally have a lower quality of life than those with a higher score.
Nine out of ten patients, however, are treated outside of clinical trials, and currently, there is no systematic attention given to cosmetic outcome assessment in these cases. At the same time, the healthcare system is experiencing pressure, leading to fewer follow-up meetings, and consequently limited attention to cosmetic outcome assessments and patient-reported outcomes (PROMs) for this patient group.
The Danish Breast Cancer Group (DBCG) has addressed this issue by developing an electronic PROMs-tool, which allows patients to regularly report on their physical and mental health from home. There is also a dedicated PROMs questionnaire (BREAST-Q) to CO, which is to be implemented nationally. In this context, DBCG expects that every fifth patient will report a fair or poor CO.
The project, supported by DCCC, has two objectives: Firstly, the applicants aim to improve the objective assessment of Cosmetic Outcomes (CO) by applying artificial intelligence to a large number of photos from Danish randomized trials. Secondly, the goal is to develop a photo tool that allows patients to perform an objective assessment of their cosmetic result themselves. This approach combines subjective BREAST-Q data with objective assessments and categorizes patients into four groups. The aim is to enhance the follow-up treatment, thus enabling the referral of patients for additional treatment based on their specific needs.
Project Name: Needs-Based Follow-Up – A New Digital Follow-Up Model in Breast Surgery Context
Principal Applicant: Ass. Professor Jasper Albertus Nijkamp, Institutte of Clinical Medicine and Danish Center for particle therapies, on behalf of the national researchcenter DCCC Stråleterapi
Amount: 500.000 DKK
How do we ensure the maximum number of disease-free years with good quality of life for each patient with chronic bone cancer?
Myelomatosis, also known as bone cancer, is a chronic disease where patients typically undergo intensive treatment over several rounds, with intervening periods when the disease is dormant. In the past two decades, there have been significant improvements in survival following myelomatosis. However, unfortunately, patients often suffer from many symptoms related to the chronic cancer and have a low health-related quality of life, even compared to other cancer patients.
Currently, patients are offered a standardized follow-up program aimed at detecting disease progression, administering continuous, maintenance, or bone-strengthening treatments, and optimizing quality of life while managing late effects.
However, both complications, late effects, and rehabilitation needs vary significantly from patient to patient, making the current standardized follow-up process suboptimal. The goal of the project, which is supported by DCCC, is thus to generate knowledge about the need for follow-up after intensive myelomatosis treatment from the patient's perspective. This knowledge will form the basis for a more targeted and individualized follow-up process, ensuring that the right help is provided to each individual in the chronic cancer course.
The project will be based on patient-reported data (PRO data) from the start of treatment and two years forward from a myelomatosis population. This PRO data is unselected, thus representing real-world data. By linking PRO data with registry data about each patient's disease course, factors affecting the patients' quality of life will be analyzed.
The knowledge generated will contribute a patient perspective linked to hard endpoints such as progression-free survival, as well as improve the effort in addressing late effects after myelomatosis treatment and enable individualized rehabilitation and follow-up. The overarching purpose of the project is thus to estimate the number of good, disease-free years with myelomatosis following different treatment regimens, which the applicant hopes can form a broader professional basis for targeted interventions in late effects, rehabilitation, and psychosocial support for those who need it.
Project Name: Disease-Free Years with Good Quality of Life – Follow-Up of Danish Patients with Myelomatosis
Principal Applicant: Lene Kongsgaard Nielsen, Senior registrar, Senior Researcher, and Clinical Lecturer. Department of Blood Diseases, Regional Hospital Gødstrup and Quality of Life Research Center, Odense University Hospital.
Amount: 500.00 DKK
RESPONSE: Can ctDNA technology and patient-oriented follow-up lead to better monitoring and treatment of late effects for colon and rectal cancer patients?
Patients who have undergone surgery for stage I and II colon and rectal cancer currently follow a standardized follow-up program, in which they are offered CT scans 12 and 36 months after the surgery. The program focuses solely on the detection of relapses, which only a few patients in this group experience.
The majority of patients, therefore, do not benefit from the follow-up program as it stands today. Conversely, up to half of all patients experience moderate to severe psychological and/or physical late effects, and there is no standardized program in place to detect and treat these. The ambition of the RESPONSE project is to change this situation.
In a researcher-initiated intervention study, information from serial blood tests, measuring the level of ctDNA, is used to identify the minority of patients who actually benefit from CT scans. CtDNA has proven to be an effective biomarker for predicting relapses with high sensitivity and specificity, and it is thus expected that this change will not diminish the chances of detecting relapses, but rather the opposite.
The change will result in the freeing up of resources, which can then be used for the ongoing monitoring and treatment of physical and psychological late effects. Physical late effects will be treated in specialized clinics for late effects, and psychological late effects will be addressed with specialized therapeutic efforts.
The new follow-up program will be supported by a digital care guide in the form of an existing app (Emento), which enhances patient autonomy. After 3 years of follow-up, the group behind the application will compare quality of life and late effects between patients in the new program and the existing program. It is expected that a comprehensive, patient-driven follow-up program will improve quality of life without compromising survival or increasing costs.
Project Name: RESPONSE:Can ctDNA Technology and Patient-Oriented Follow-Up Lead to Better Monitoring and Treatment of Late Effects for Colon and Rectal Cancer Patients?
Principal Applicant: Peter Christensen, Professor, Chief Physician, Gastrointestinal Surgery, Aarhus University Hospital, on behalf of the RESPONSE group.
Amount: 500,000 DKK
Can ctDNA be used as an effective guide in the treatment monitoring of lung cancer patients?
There is significant variation in the effectiveness of treatments for lung cancer patients. Therefore, it's important to monitor whether the treatment of an individual patient is effective, to avoid ineffective, side-effect-laden, and expensive treatments that ultimately could lead to decreased quality of life and survival. Currently, monitoring of patients with incurable lung cancer involves a standardized treatment course focused on scheduled CT scans.
The purpose of the national, randomized intervention study, which DCCC supports, is to investigate whether the detection of ctDNA in blood samples can replace standard CT scans in the treatment and control courses for patients with incurable lung cancer. The goal is a more precise and individualized monitoring and follow-up, which potentially can spare patients unnecessary treatments and side effects – and also save the healthcare economy from unnecessary CT scans.
Besides the randomized study, which expects to include a total of 350 patients, health economic cost-benefit calculations are also being conducted in connection with the project. The assessment of effectiveness includes the number of cancer treatments received, side effects, and expenses related to side effects (medication, hospitalizations, consultations) and quality of life. This makes it possible to precisely determine whether monitoring this patient group via blood tests rather than CT scans can benefit both the patients and the healthcare economy. The applicant assesses that the results of the study could become the foundation for changing clinical practices for treatment monitoring and follow-up of lung cancer patients.
Project Name: Circulating tumor DNA guided treatment monitoring in advanced lung cancer – a randomized interventional study
Principal Applicant: Malene Støchkel Frank, Consultant, Clinical Research Associate Professor of Oncology. Department of Clinical Oncology and Palliative Care
Amount: 500.000 DKK
Can we improve detection and follow-up for women treated for vulvar cancer?
Vulvar cancer, a rare disease affecting the female external genitalia, has not previously received much research attention. The treatment, which most often consists of surgery and possibly adjunctive radio-chemotherapy, carries a high risk of late effects and is also associated with a high risk of recurrence.
The current standardized follow-up program consists of consultations and gynecological examinations. Currently, the detection of lymph node metastases and the occurrence of the skin disease lichen sclerosus, followed by precancerous dVIN (differentiated vulvar intraepithelial neoplasia), are the only known clinical biomarkers for recurrence. Allocation to postoperative radio-chemotherapy occurs in the presence of lymph node metastases, and the follow-up is the same for all patients.
The project, supported by DCCC, aims to optimize the current follow-up program by investigating whether specific warning symptoms can predict a recurrence of the disease, and whether the response to questionnaires, combined with algorithm-determined phone contact during the follow-up process, can contribute to the early detection of recurrence and early identification of patient-reported late effects. Furthermore, the applicants wish to investigate whether relevant circulating tumor DNA (ctDNA) can be identified in blood samples from patients with vulvar cancer, so that ctDNA can be used in the future for improved allocation of patients to adjunctive treatment and for earlier recurrence detection in the follow-up process.
Project Name: The value of patient reported outcome measure assessment and circulating tumor DNA to detect early relapse during surveillance in women with vulva cancer.
Principal Applicant: Louise Krog, Ph.D. Candidate, Department of Obstetrics and Gynecology, Aarhus University Hospital and Aarhus University
Amount: 496.200 DKK
